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Medical Devices Regulatory Consulting Requests |
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Global Regulatory.com has received the following incoming Medical Devices Consulting Requests which need to be fulfilled ! These Medical Devices Consulting Requests are received from a variety of sources ranging from start-up companies to large, multinational corporations actively seeking consultants to perform their Medical Devices consulting services. If your company receives requests that it can not fulfill, please refer them to us! If you have questions, please e-mail Global Regulatory or call 403-770-1994 .
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Incoming Medical Devices Consulting Requests
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# |
Medical Devices consulting request description |
status |
| 12-000078 |
Dental Manufacturer that wishes to market in France needs medical device consultant:
1. Medical devices: Dental implants systems (implants, prosthetic abutments and surgical instruments). These pr ( read more )..... |
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| 12-000076 |
Medical device regulatory consulting and services for: Uruguay, Paraguay, Bolivia, Chile, Equador, Peru, Colombia, Venezuela, Suriname, Nicaragua, Costa Rica, Mexico, Guatemala and Cuba.
( read more )..... |
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| 12-000068 |
South America Medical Device Consultant needed to provide medical device regulatory consulting for: Uruguay, Paraguay, Bolivia, Chile, Equador, Peru, Colombia, Venezuela, Suriname, Nicaragua, Costa Ri ( read more )..... |
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| 12-000064 |
We are producing medical devices - laser delivery system/ connectors. Soon we will enter the USA market and would like to preparing all FDA Consultant needed for FDA Training staff for USA FDA inspec ( read more )..... |
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| 12-000061 |
Prosthesis Manufacturer needs FDA Consultant for medical device FDA consulting for new prosthesis including identifying a similar device; 2.Which FDA pathway is relevant for FDA submission? 3.What typ ( read more )..... |
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This webinar on sterility or bioburden test for medical devices will discuss about the various items that should be investigated to determine the root cause, when a failure occurs during a sterility t ( read more )..... |
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| 12-000058 |
Medical Device Manufacturer preparing to enter the USA market needs FDA Regulatory Consultant for preparing all the staff for USA FDA inspection and trainings regarding Preparing FDA Quality system in ( read more )..... |
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| 12-000051 |
US FDA Consultant needed for 510k Submission on LED heat lamp - Create a Risk Assessment or Risk Management Report in accordance with ISO 14971 including ongoing policies and practices needed for qual ( read more )..... |
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| 12-000039 |
Medical Device Regulatory Consultant needed for Compliance Consulting / Regulatory Authorized Representative ( read more )..... |
Closed |
| 12-000028 |
U.S. company needs regulatory consultant knowledgeable in the preparation of technical manuals and package inserts for in vitro diagnostics to be sold in European and domestic markets. We require cons ( read more )..... |
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| 12-000023 |
Medical Device Regulatory Consultant needed for Ce marking forclass IIa medical device ( read more )..... |
Closed |
| 12-000019 |
Singapore Medical Device Regualtory Consultant needed for Singapore HSA product registration for medical device GDPMDS certification ( read more )..... |
Closed |
| 12-000004 |
Australian manufacturer of a class II device with FDA, TGA approval and CE mark looking for Regulatory Consultant for Argentina, Mexico, Brazil, India , Singapore as our next target markets and will ( read more )..... |
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| 12-000002 |
In-Vitro diagnostics IVD FDA Regulatory consultant to assist with clinical trials and 510(k) submissions for FDA Class I and II devices.
( read more )..... |
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The meanings and regulatory requirements of the terms "verification" and "validation" are often confusing to engineers and even some regulatory professionals. Operations managers are even less well v ( read more )..... |
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While most clinical research professionals are familiar with US pharmaceutical regulations, many have no experience with regulated research involving medical devices, or their experience is primarily ( read more )..... |
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| 11-000122 |
Biologic Manufacturer needs ex FDA CDRH inspector to conduct a mock 21CFR820 audit at our manufacturing facility. ( read more )..... |
Closed |
| 11-000113 |
ISO 9001, ISO 13485 certified Medical Device Manufacturer certified as ISO 9001, ISO 13485 & CE Marking would like South America Regulatory Consultant to assit with registrations in Brazil, South Amer ( read more )..... |
Closed |
| 11-000110 |
Australia Medical Device Manufacturer needs South America Regulatory Consultant to provide assistance to re-new health permits for medical devices sold in Peru ( read more )..... |
Closed |
| 11-000109 |
breast Cancer diagnostic manufacturer needs Mexico Regulatory Consultant to assist in gaining approval in Mexico ( read more )..... |
Closed |
| 11-000096 |
Small medical device distribution company needs Quality Consultant for Standard SOP's and Tissue Banking SOP's for storage and distributions and a quality system put in place. ( read more )..... |
Closed |
| 11-000094 |
Large Generic Pharmaceutical Manufacturer needs regulatory consultant to advice on Indian legislations needed for medical devices in order to maintain regulatory affairs ( read more )..... |
Closed |
| 11-000093 |
Regulatory consultancy needed for registering a medical divice (CE Marked according to MDD93/42, Class III) in Argentina, Chile, Venezuela and Colombia. The product is a hyaluronic acid (HA) intraart ( read more )..... |
Closed |
| 11-000089 |
ISO13485 certified medical device manufacturer with pending CE Mark Certification would like to apply for FDA approval. Believe our product is exempt from 510K submission but we still need to confirm ( read more )..... |
Closed |
| 11-000084 |
Medical device manufacture which is ISO13485 certified and waiting on our CE Certification to come through this month. Our next step is to apply for FDA, we have been told that our product is exempt ( read more )..... |
Closed |
| 11-000073 |
Clinical diagnostic manufacturer needs Mexico Regulatory consultant for assistance in registering clinical chemistry analyzers and reagents in Mexico. ( read more )..... |
Closed |
| 11-000067 |
Preferably Delaware local regulatory consultant needed to carry out a needs analysis, design training and possibly deliver training to meet the regulatory needs of our customers ( read more )..... |
Closed |
| 11-000060 |
Small medical device implant company needs FDA consultant familiar with FDA/ISO/EU/TGA for on-call and/or on-site (when needed) regulatory consultant familiar with FDA/ISO/EU/TGA guidelines. ( read more )..... |
Closed |
| 11-000052 |
Brazil Business and Regulatory consultant needed for advising US medical device companies interested in entering Brazil market ( read more )..... |
Closed |
| 11-000051 |
FDA will be performing FDA GMP, Part 11.Require FDA Inspection training preparation for IT Department. ( read more )..... |
Closed |
| 11-000046 |
Medical Device Consultant needed to file 510K submission for IVD In-Vitro Diagnostic. ( read more )..... |
Closed |
| 11-000040 |
Regulatory consultant needed to advise on regulatory requirements for labeling, packaging and international shipping of a pre-saturated wipe and swab. ( read more )..... |
Closed |
| 11-000032 |
Regulatory Consultant needed to advise on Regulatory Requirements for Importation into the Caribbean countries:
Turks and Caicos Islands
Jamaica
Trinidad and Tobago
Dominica ( read more )..... |
Closed |
| 11-000030 |
Asia consultant needed to register contact lens product in Thailand. ( read more )..... |
Closed |
| 11-000027 |
Medical Device Consultant needed for regulatory strategy consulting for Brazil, China, India and Japan: 1/ Prepare a strategic plan (including steps, requirements, budget & timeline) for registratio ( read more )..... |
Closed |
| 11-00020 |
Large device company needs regulatory consultants to assist in regulatory strategy of regulatory needs in various countries around the world w.r.t. localization. ( read more )..... |
Closed |
| 11-00019 |
United States Medical Device Manufacturer owns a foreign manufacturer of rapid tests needs medical device consultant for Third Party Review or FDA submissions for 510K ASAP for Class II disposable fil ( read more )..... |
Closed |
| 11-00011 |
Israel Regulatory Consultant to advise on needed costs and time of registering dental medical devices in Israel. Need qualified agent in Israel to perform registration activities, maintain registrati ( read more )..... |
Closed |
| 11-00008 |
United States Medical Device Manufacturer owns a China manufacturer of rapid tests needs medical device consultant for FDA submissions for OTC 510K ASAP for the following products froups):
1. Rapid ( read more )..... |
Closed |
| 11-00005 |
USA Medical Device Manufacturer needs Regulatory Consultant for Product Registrations in Brazil and India as well as other countries in the future. ( read more )..... |
Closed |
| 10-00172 |
Medical Device Manufacturer needs Local regulatory consultant in Philippines who has already secured a License to Operate (LTO) from Philippines FDA, so as to assist us in product registrations of ou ( read more )..... |
Closed |
| 10-00171 |
India Class I medical devices manufacturing firm needs India Regulatory Consultant for US FDA 510 K submission.
( read more )..... |
Closed |
| 10-00166 |
Medical Device Consultant needed for FDA 501k submission (class II device with predicate approved devices).... device is software and hardware
Need assistance completing design review 2 to 4
Need as ( read more )..... |
Closed |
| 10-00160 |
Large Pharma needs Regulatory Consultant to provide regulatory support for a new healthcare diagnostic to enter Hong Kong and China. ( read more )..... |
Closed |
| 10-00156 |
Regulaotry Consultant Needed to Register our Class 1 Medical Device to South Africa,Kuwait, Lebonon,South Korea and UAE,Thailand and Philippines. ( read more )..... |
Closed |
| 10-00152 |
FDA Medical Device Consultant needed for 510K submission for medical devices made in China ( read more )..... |
Closed |
| 10-00147 |
Regulatory Consultant needed to register medical device in Costa rica,UAE and South Africa. ( read more )..... |
Closed |
| 10-00142 |
India Wound cleansing wipes Manufacturer (0.4% Benzolkonium chloride - comes under drug category) used in FIRST AID KITS needs regulatory company to register with HEALTH CANADA ( read more )..... |
Closed |
| 10-00137 |
Europe or Middle East based Regulatory Consultant needed for GCC regulatory requirements. Our first target countries would be Kuwait and Saudi Arabia.
1.- Regulatory documentation to submit (list ( read more )..... |
Closed |
| 10-00134 |
Medical Device regulatory consultant needed for biomedical medical device firm. ( read more )..... |
Closed |
| 10-00131 |
Regulatory consultant needed for advising on diagnostic regulatory scheme in a variety of countries for molecular diagnostics as well as IVDMIA's. Also need insights into the reimbursement process in ( read more )..... |
Closed |
| 10-00125 |
Medical Device Manufacturer needs GMP Consultant for GMP Vendor Audit ( read more )..... |
Closed |
| 10-00112 |
Medical Device Company needs Consultant to advise on Import regulations for hand-held IEC Class 2 laser projector into the following countries:
North America
o United S ( read more )..... |
Closed |
| 10-00110 |
Netherlands CE certified Medical device & consumable company (ophthalmic products) needs regulatory consultant for registration in Latin American countries, especially Mexico and Argentina. All our p ( read more )..... |
Closed |
| 10-00107 |
Export / Import Consultant needed to advise on shipping biomedical products to Europe and Canada ( read more )..... |
Closed |
| 10-00106 |
Consultant needed to assist in commercialization of a diagnostic test. The test is an immunohistochemistry (IHC) test applicable to Leica, Dako, and Ventana instrument platforms. We are currently runn ( read more )..... |
Closed |
| 10-00099 |
Medical Device Manufacturer needs Regulatory Consultant to Register contact lens products in UAE ( read more )..... |
Closed |
| 10-00083 |
Brazil Regulatory Expert needed for Registration of products in Brazil: instruments and reagents. ( read more )..... |
Closed |
| 10-00079 |
Regulatory expert needed advisory services for Class III products for interventional cardiology. All products are CE marked. ( read more )..... |
Closed |
| 10-00073 |
USA based company seeking regulatory consultant who can help us to register our rapid ivd screening devices in Mexico's "FDA" equivalent (COFEPRIS?). ( read more )..... |
Closed |
| 10-00069 |
Medical Device Manufacturer needs FDA Regulatory Consultant for 510K approval
Classification Panel: Radiology Diagnostic Devices
Classification name: Positron Camera, Class I, 21 CFR § 892.1110
Pr ( read more )..... |
Closed |
| 10-00068 |
NY Medical Device Manufacturer seeks long term regulatory and quality management consultant, Maintenece of FDA, CE, ISO compliance, update of technical file, Internal quality audits. minimum 2 days at ( read more )..... |
Closed |
| 10-00066 |
FDA Consultant needed to Act as the company's independent regulatory representative with FDA (one-year assignment to: Monitor registration of manufacturing establishment with FDA (idem.)
3. Mo ( read more )..... |
Closed |
| 10-00061 |
Medical Device Manufacturer needs Quality Consultant to assist in sterilizaiton validation to comply with ISO 17664 - Sterilization of medical devices -Need to comply with the above ISO standard. Nee ( read more )..... |
Closed |
| 10-00060 |
Regulatory consultant needed to assist with registrations in Brazil. It would be a bonus if that company had an office in Brazil and could be our in country rep (BRH) as well as provide any input on ( read more )..... |
Closed |
| 10-00059 |
Medical Device Manufacturer needs Regulatory Consultant for assistance in gaining presence in Mexico, India, China; specifically with the incountry regulatory filings, importation requirements, the ne ( read more )..... |
Closed |
| 10-00045 |
Medical Deice Consultancy required for India FDA Licensing for import of Class-III mdeical devices into India ( read more )..... |
Closed |
| 10-00043 |
Medical Device Consultant needed for FDA Internal audit assistance ( read more )..... |
Closed |
| 10-00038 |
Quality Consultant needed for analyzing, recommending and assisting in the preparation of documents and operating procedures, including the Master/Validation Plan(s), for GXP areas such as computer sy ( read more )..... |
Closed |
| 10-00034 |
REGULATORY CONSULTANT NEEDED TO FILE SEVERAL ITEMS WITH HEALTH CANADA: NPNs, COSMETICS OR MEDICAL DEVICE (SUCH AS DENTURE TABS). ( read more )..... |
Closed |
| 10-00029 |
Medical Device Manufacturer seeking a well rounding medical device consultant or consulting team that can advise of gaps in our regulatory compliance for a broad range of regulating bodies. This list ( read more )..... |
Closed |
| 10-00026 |
EU Regulatory Consultant needed for EU CTD (CAPA service required), also EMEA Regulatory filings, also clinical monitoring.
( read more )..... |
Closed |
| 10-00018 |
Start-up "private label' medical syringes importer needs Toronto regulatory consultant for guidance about filing for the necassary licences for USA FDA and Canada (What should the importer do and what ( read more )..... |
Closed |
| 09-0182 |
India independent consultant needed to assist on regulatory affairs for a US company for import of medical devices into India ( read more )..... |
Closed |
| 09-0179 |
FDA Medical Device Consultant needed for FDA PMA, 510(k) Approval Training ( read more )..... |
Closed |
| 09-0175 |
Medical Device Consultant needed for Pre market Approvals for Class I, II, III, Medical Devices
For USA, Europe, Canada
ISO 13485:2003 CMDCAS Implementation
ISO Training
Trade Complaint Handling
( read more )..... |
Closed |
| 09-0170 |
Medical Device Regulatory Consultant needed for FDA 510K and CE submission for Class IIa medical devices. ( read more )..... |
Closed |
| 09-0169 |
Singapore Contact Lens Manufacturer seeking local representative to register products in US. ( read more )..... |
Closed |
| 09-0166 |
Singapore medical device manufacturing company seeking Australia and New Zealand local representative to register products ( read more )..... |
Closed |
| 09-0165 |
Contact Lens manufacturer in Singapore seeking medical device consultants to register products in Saudi Arabia, UAE and Kuwait.
( read more )..... |
Closed |
| 09-0160 |
Medical Device Regulatory Consultant and Expert witness in a binding arbitration case involving the sale of a device. ( read more )..... |
Closed |
| 09-0153 |
Medical Devices Manufacturer needs medical device consultant to advise on class II diode laser, 980nm machine for submission. ( read more )..... |
Closed |
| 09-0150 |
UK Medical Device Company needs Regulatory Consultant to advise on medical device registration/licensing around the world but particularly in markets introducing new legislation. Consultancy advice r ( read more )..... |
Closed |
| 09-0112 |
Consultant to bring the GMP compliant facility into US FDA Medical Device compliance. ( read more )..... |
Closed |
| 09-0104 |
Regulatory Consultant needed to register to sale the product in Japan ( read more )..... |
Closed |
| 09-0099 |
Medical Device Manufacturer needs medical device consultant to advice on packaging and labeling of the device. ( read more )..... |
Closed |
| 09-0097 |
Beijing, China Medical Device Manufacturer needs agent to advise on Brazil medical device registration ( read more )..... |
Closed |
| 09-0092 |
Small French Pharmacy company needs agency in India for registration of innovative Medical devices containing Glycerol+Honey and a traditional plant extract for topical application on wounds.
( read more )..... |
Closed |
| 09-0088 |
US subsidiary of large global medical devices company requests assistance with product registration in Latin America and Mexico. ( read more )..... |
Closed |
| 09-0086 |
Regulatory consultant needed that can provide assistance with Russian technical submission and act as local authorised representative. ( read more )..... |
Closed |
| 09-0076 |
US FDA Consultants needed for FDA 510K submission of synthetic medical devices (surgical gloves) ( read more )..... |
Closed |
| 09-0070 |
Medical Device Mfg needs Registered Agent & US FDA Medical Device Consultant to assist on Medical Device Registration - Puerto Rico
( read more )..... |
Closed |
| 09-0068 |
Large Medical Device Mfg needs quality consultants to write Quality Manual, training personnel, generate procesess and document control matrix, revision of existing procesess & finally implementation. ( read more )..... |
Closed |
| 09-0062 |
Medical Device Manufacturer seeking local representative to register medical device-cosmetic contact lens in Brazil ( read more )..... |
Closed |
| 09-0056 |
Liposuction equipment, products and supply company needs FDA regulatory consultant for FDA compliance ( read more )..... |
Closed |
| 09-0049 |
Manufacturer of FDA and EU approved, non-invasive bp monitors requires specialty regulatory consultation for markets in South America/Africa/Asia/Eastern Europe. ( read more )..... |
Closed |
| 09-0043 |
A 3rd party service to act or coordinate on behalf of our company to import medical devices globally for clinical trial use.(The primary need is for clinical trial use and the secondary need is for sa ( read more )..... |
Closed |
| 09-0042 |
Cosmetic Contact Lens company seeking regulatory consultants or local representative in Mexico for product registration service. (do not want distributors) ( read more )..... |
Closed |
| 09-0033 |
Manufacturer of clinical diagnostic controls nearing the completion of addressing an FDA warning letter needs FDA Medical Device Consultant to conduct a "mock" QSIT re-inspection to ensure cGMP compli ( read more )..... |
Closed |
| 09-0031 |
Hong Kong Medical Device Manufacturer needs Brazil Import / Eport consultant to assist in importing US FDA approved medical devices in Brazil. ( read more )..... |
Closed |
| 09-0022 |
European manufacturer of dental class 3 and class 2 implants needs regulatory consultant for FDA 510k to enter US market. ( read more )..... |
Closed |
| 09-0021 |
Medical Device Manufacturer needs Regulatory Consultant to register Medical Devices in Mexico. All devices already have FDA 510(k) clearance. ( read more )..... |
Closed |
| 09-0014 |
Italy Medical device manufacturer needs regulatory consultant for assistance filing FDA Pre-Market Notification (510K) for medical device used for diabetic foot ulcers.
( read more )..... |
Closed |
| 09-0006 |
Medical Device Regulatory Expert in Brazil familiar with ANVISA registration process needed to assist and to provide information about the clinical trials that are required for Class I medical devices ( read more )..... |
Closed |
| 09-0002 |
Medical Device Regulatory Consultancy Firm needed to register medical devices with Egypt Ministry of Health. ( read more )..... |
Closed |
| 08-0171 |
Medical Device Manufacturer needs medical device consultant to register our Class II cosmetic contact lenses device in Mexico. The device is has CE Marking. ( read more )..... |
Closed |
| 08-0156 |
Medical Device Manufacturer needs Medical Device COnsultant to assist in 510K pathway with a device that is very similar to several devices approved by the FDA. I am also looking into European approv ( read more )..... |
Closed |
| 08-0150 |
Consultants or training courses needed for lead auditors training against FDA regulations specificially 21 CFR part 820
( read more )..... |
Closed |
| 08-0137 |
New Zealand Manufacturer seeks GMP Consultant Based in China that knows the TGA GMP regulatory requirements. ( read more )..... |
Closed |
| 08-0135 |
Medical Device Manufacturer needs medical device consultant to register our Class II electronic brachytherapy device in Mexico. The device is fully FDA 510(k) cleared. ( read more )..... |
Closed |
| 08-0132 |
Pharmaceuticals Regulatory Consults needed to assist in product development related to NCE (New chemical entity) and apply that to the medical devices we are currently developing. Therefore we want to ( read more )..... |
Closed |
| 08-0118 |
India Pharmaceutical Manufacturer needs FDA medical device regulatory consultant to assist on 510(k) Approval ( read more )..... |
Closed |
| 08-0113 |
NY Metropolitan Area Medical Device Regulatory Consultant needed for FDA Quality Assurance / Regulatory Affairs assistance including: Batch record & review, electronic records, Quarterly quality syste ( read more )..... |
Closed |
| 08-0112 |
Canada Medical Device Manufacturer needs FDA Consultant to do FDA mock audit done to prepare for possible FDA audit. Our products are medical devices such as flowmeters, gas regulators, hoses, vacuum ( read more )..... |
Closed |
| 08-0111 |
Large CRO needs 2 Validation Consultants to validate BioRad Bioplex (Luminex) & iQ5 thermocycles. Installation Qualification / Operational Qualification (IQ/OQ) already done. Have in-house method val ( read more )..... |
Closed |
| 08-0110 |
Medical Device Regulatory Consultant needed who can assist us with our marketing efforts of a medical device in the EU. Knowledge of regulatory requirements and process are required. ( read more )..... |
Closed |
| 08-0103 |
Electronics Medical Device Manufacturer needs Regulatory consultant to advise on compliance and adherence to AERB, PNDT and other medical devices regulations required in Indian market. Also regularly ( read more )..... |
Closed |
| 08-0101 |
Medical Device Consultant needed to submit an SFDA for product approval of implantable orthopedic products(medical devices) ( read more )..... |
Closed |
| 08-0100 |
Medical Device Validation Experts located in Germany needed immediately for Design Validation of electro-mechanical-pneumatic design validation protocols written, tests performed and validation report ( read more )..... |
Closed |
| 08-0095 |
Experienced FDA Medical Device Regulatory Consultants needed to register 510(k) biliary, esophageal stents with the FDA. i would like to contact a experienced professional who can help with 510k.
( read more )..... |
Closed |
| 08-0092 |
Medical Device Regulatory Consultant needed to provide a regulatory overview of the Middle East's regulation requirmenents of medical devices. ( read more )..... |
Closed |
| 08-0088 |
Regulatory professional needed to help geeting ISO and CE Medical Device approved by Health authorities in Asia and Middle east. Our device holds CE and ISO. ( read more )..... |
Closed |
| 08-0069 |
Regulatory Consultant needed for advising and planning for a combination product with a device PMOA.Product is a monitoring system with a injected dye.Anticipate IDE and PMA in the US. ( read more )..... |
Closed |
| 08-0063 |
Need regulatory consultant to help obtain CE mark for products ( read more )..... |
Closed |
| 08-0056 |
Medical Device Regulatory Consulting FIrm needed to do Required Summery of product characteristic (SPC)of Loette registered in austria. ( read more )..... |
Closed |
| 08-0055 |
MEDICAL DEVICE REGULATORY CONSULTANT TO ASSIST IN GETTING MEDICAL DEVICE APPROVED ASAP. ( read more )..... |
Closed |
| 08-0049 |
Medical Device Start-Up needs regulatory consultant to set-up GLP training session to build GLP awareness and eventually become GLP compliant. ( read more )..... |
Closed |
| 08-0043 |
Medical device consultant needed for validation of manufacturing equipment and process validation ( read more )..... |
Closed |
| 08-0037 |
Regulatory consultant needed to register our FDA approved product in Mexico. ( read more )..... |
Closed |
| 08-0034 |
Regulatory Consultant needed for advice on registering Class III medical device for distribution in various Middle East countries e.g. Saudi Arabia, U ( read more )..... ( read more )..... |
Closed |
| 08-0033 |
Manufacture of insertion tubes for endoscopy scopes needs Medical Deivce Regulatory Consultant to advise on insertion tubes are used by third party repair companys. In additon we refinish scopes with ( read more )..... |
Closed |
| 08-0022 |
Regulatory consultant needed who can aid us through the process of "FDA" equivelant for Mexico in the medical device area. ( read more )..... |
Closed |
| 08-0021 |
CE marking consultant needed to consult on CE Marking from Canada to Europe ( read more )..... |
Closed |
| 08-0019 |
Regulatory Consultant needed to manage or assist in registration of orthopedic implant medical devices in Mexico. All products have US FDA and CE clearance. ( read more )..... |
Closed |
| 08-0017 |
Regulatory Consultant needed for repackaging and relabelling located in Reno NV ( read more )..... |
Closed |
| 08-0016 |
FDA Regulatory Consultant needed for assisting in getting a medical device product approved. It may be under an HDE or possibly grandfathered. However a 510k Approval would be preferred. ( read more )..... |
Closed |
| 08-0012 |
Regulatory Consultant needed to consult on distributing medical products in the Middle East. Do I need to get any documents before doing the trading business? What kinds of regulatory that I should sa ( read more )..... |
Closed |
| 08-0011 |
Regulatory consultant needed for regulatory requirements concerning the product and if there are any trade regulations that we should be addressing. We would like to sell, rightfully distribute a sing ( read more )..... |
Closed |
| 08-0009 |
Medical Device Company needs conusltant for medical device registrar services ( read more )..... |
Closed |
| 08-0008 |
Regulatory Medical Devices Consultant needed for consulting on device for early detection of cancer prostates and bladder ( read more )..... |
Closed |
| 07-0133 |
Leading Global Medical Devices organistion requires regulatory consultant for urgent assistance required in writing, compiling and filing 510K submissions of various products. You must be able to hit ( read more )..... |
Closed |
| 07-0131 |
Company with new molecular diagnostic under development needs regulatory consultant with both FDA and CLIA "homebrew" experience to assist in the evaluation of the appropriate regulatory strategy. Mu ( read more )..... |
Closed |
| 07-0129 |
Medical Device regulatory consultant needed to register implantable device in UAE. ( read more )..... |
Closed |
| 07-0126 |
Quality Consultant needed for conducting a Quality System Audit of a factory in Beijing, China, to ensure compliance with FDA QSR for medical device manufacturing. ( read more )..... |
Closed |
| 07-0110 |
Regulatory Consultant needed for advising on Health Permits for medical Devices, mainly Odontological products ( read more )..... |
Closed |
| 07-0103 |
Regulatory consultants needed to develop Regulatory Strategy and FDA submission for InVitro Diagnostic Assays ( read more )..... |
Closed |
| 07-0094 |
Medical Device Consultant needed for advising on the standard of inspection level for raw material medical devices ( read more )..... |
Closed |
| 07-0093 |
Medical Device Consultant needed to advise on regulatory requirements needed to launch a hospital patient tracking software. ( read more )..... |
Closed |
| 07-0090 |
Medical Device Regulatory Consultant needed for advising on procedures for introducing screening tests/rapid diagnostic tests for TB, Sleeping Sickness and Malaria to Kenya for routine application and ( read more )..... |
Closed |
| 07-0087 |
Medical Device Regulatory Consultant needed for assisting in the registration of in vitro diagnostic fevices for infectious disease in Kenya (IVD for TB, Malaria and Sleeping sickness out of bodily f ( read more )..... |
Closed |
| 07-0070 |
Medical device manufacuter seeks consultant for gaining clearance in Canada for device with 510(k) clearance and CE approval ( read more )..... |
Closed |
| 07-0068 |
Regulatory Consultant needed for Registration of Medical devices (manufactured & imported from Australia )and to be Marketed in India. ( read more )..... |
Closed |
| 07-0053 |
Regulatory and clinical trial consultancy required for FDA submission of ultrasound based CAD system. Experience and expediency with imaging sector device and software must be demonstrable. ( read more )..... |
Closed |
| 07-0049 |
Regulatory Consultant needed for advice on registering Class III medical device for distribution in various Middle East countries e.g. Saudi Arabia, United Arab Emirates ( read more )..... |
Closed |
| 07-0048 |
Consulting group needed to register Class I & II medical devices for distribution, various countries in South America, Latin America ( read more )..... |
Closed |
| 07-0042 |
Medical Device Manufacturer needs Regulatory Consulting Firm to advise on current regulations regarding submission for new medical device in South Africa ( read more )..... |
Closed |
| 07-0041 |
Regulatory Consulting Firm needed for Class II Medical Device Submission. ( read more )..... |
Closed |
| 07-0037 |
Consultant company needed to register software systems for medical image interpretation with ANVISA in Brazil and to maintain that registration as our representative for regulatory purposes in Brazil. ( read more )..... |
Closed |
| 07-0036 |
Regulatory Affairs Consultant needed for registration
of a Medical Device (CE marked & FDA
approved) in Japan ( read more )..... |
Closed |
| 07-0032 |
Medical Device Regulatory Consultant needed for GMP Audits for medical devices ( read more )..... |
Closed |
| 07-0030 |
Regulatory/Clinical support needed for Dermal Filler FDA PreMarket Approval PMA ( read more )..... |
Closed |
| 07-0027 |
Regulatory consultant needed to register medical devices in Soth Africa, Saudi Arabia, Kuwait, Malaysia, Singapore, Jordania and Thailandia ( read more )..... |
Closed |
| 07-0025 |
Regulatory consultant needed for advising on Israeli requirements on cleaning, decontamination and sterilization processes for new Medical equipment or used (refurbished medical equipment).Law extract ( read more )..... |
Closed |
| 07-0014 |
Clinical Consultant needed for clinical trials training in pharmaceuticals,medical devices,cosmetics,food and beverages ( read more )..... |
Closed |
| 07-0005 |
Medical Device manufacturer needs regulatory consutlant for advise related to registration of medical device in Latin America, which is already registered under European MDD, and Canadian MDD. ( read more )..... |
Closed |
| 06-0177 |
Medical Devices manufacturer needs assistance with product registration and clinical studies ( read more )..... |
Closed |
| 06-0171 |
Medical Device company needs GLP consultant on setting up a preclinical medical device laboratory for GLP compliance. ( read more )..... |
Closed |
| 06-0170 |
Medical Device company needs consulting on it's first class II medical device 510k filing. ( read more )..... |
Closed |
| 06-0161 |
Disinfectant solution manufacturer wants to supply this product to Canada as a medical device. We want to claim the product sterile and will use a RABS to achieve class A in C environment and need to ( read more )..... |
Closed |
| 06-0160 |
IVD Medical Device and Novel Therapy System Manufacturer needs Consultant for advising on market entry requirements for medical device in Russia, India, Brazil, Mexico, Australia, Thailand, Malaysia, ( read more )..... |
Closed |
| 06-0159 |
Medical Device Consultant needed who is familiar with medical device regulations in South Africa and who can assist in getting approval for registering and marketing there.
( read more )..... |
Closed |
| 06-0157 |
Need information regarding setting up clinical trials in Romania. ( read more )..... |
Closed |
| 06-0139 |
Dental Instrument Distributor needs FDA and ISO 9001 consultant for consulting related to shipping issues with Korea. ( read more )..... |
Closed |
| 06-0136 |
Antimicrobial fiber manufacturer needs legal or regulatory consultants experienced in medical devices regulations in Mexico. We are interested in selling protective and surgical clothing incorporatin ( read more )..... |
Closed |
| 06-0133 |
GLP consultant needed for setting up a preclinical medical device laboratory for GLP compliance ( read more )..... |
Closed |
| 06-0131 |
Regulatory consultants needed for obtaining USFDA PMA for Implanable Pacemakers, Titanium Dental Implants . ( read more )..... |
Closed |
| 06-0129 |
Full service Regulatory Consultant needed with expertise in orthopedic implants and a proven trackrecord of Medical Device product registration in Mexico.
( read more )..... |
Closed |
| 06-0128 |
Spanish speaking GMP consultants needed for GMP manufacturing system development for in-vitro diagnostic manufacturing facility in Spain. Location is already CE approved for manufacturing in the EU. ( read more )..... |
Closed |
| 06-0125 |
Regulatory consultant needed for Class 1 Medical Device Technical File ( read more )..... |
Closed |
| 06-0122 |
International company needs FDA consultancy for 510(k) registration of dentifrice containing Fluoride, Potassium nitrate and another active ingredient inducing growth of tooth-analog material ( read more )..... |
Closed |
| 06-0116 |
UK regulatory consultant needed for consulting on licensing and importing of medical devices. ( read more )..... |
Closed |
| 06-0104 |
Regulatory consultant experienced with combination products (medical devices/pharmaceuticals) approval process in the UK needed for providing outline of regulatory approval process. ( read more )..... |
Closed |
| 06-0085 |
Medical Device Regulatory Consultant needed for providing assistance for filing PMA of orthopedic bone cement. Consultant must be knowledgeable of new regulatory laws for medical devices in Japan and ( read more )..... |
Closed |
| 06-0083 |
Medical Device Manufacturer of active implantable devices seeks consultant to advise on regulatory approval process in Australia. ( read more )..... |
Closed |
| 06-0081 |
Medical Device regulatory and translation services needed for approval and guidance on OTC Oral Health Products. Translation into 17 EU official languages including allowable claims and required text ( read more )..... |
Closed |
| 06-0070 |
Medical Devices Manufacturer needs ISO, FDA GMP Contract Sterilizer needed for gamma or e-beam sterlization of medical devices"
( read more )..... |
Closed |
| 06-0069 |
Medical Device Manufacturer needs MDD 93/42 EEC training provided on-line 93/42 including essential requirements, & technical files training for Cls I & II Medical device Mfg. /Adm. personnel. Afforda ( read more )..... |
Closed |
| 06-0065 |
Medical Device FDA GMP consultants needed for plant design and set-up new of new medical device manufacturing plant. ( read more )..... |
Closed |
| 06-0059 |
Regulatory consultants experienced with EU and US PMA needed for product development team (approximately 4-8 hours per week) to ensure compliance with US FDA PMA, and EU regulations. Person will tran ( read more )..... |
Closed |
| 06-0058 |
Medical Device Manaufacturer needs experienced regulatory consultant needed, preferably that speaks Japanese, for completion of Shonin application under PAL requirements for a PTCA device at our pare ( read more )..... |
Closed |
| 06-0056 |
Medical Devices ISO, GLP, GMP, GCP Regulatory Consultants needed for Medical Device Evaluation for multiple medical devices and In-Vitro Diagnostics to Regulations
-ISO, GLP, GMP and GCP. For Dispos ( read more )..... |
Closed |
| 06-0054 |
ISO Quality consultant needed for Lead Assessor training on ISO 13485:2003 and QSR 820 ( read more )..... |
Closed |
| 06-0053 |
Multinational Medical Devices Manufacturer needs validation consultant for providing process validation training. ( read more )..... |
Closed |
| 06-0052 |
Medical Device company in Israel needs consultant for internal, 1 day biocompatibility and sterilization (EO) training
( read more )..... |
Closed |
| 06-0047 |
Medical Device Regulatory Consultants needed to establish overall regulatory strategy including filing 510k with US FDA and setting up internal QSR for for a new disposable safety syringe medical prod ( read more )..... |
Closed |
| 06-0038 |
Medical Device manufacturer needs consultants to assist with FDA medical device registration and approval filings for medical tubing for IV solution bags and lay flat tube Consulting needed to guide ( read more )..... |
Closed |
| 06-0033 |
Medical Device manufacturer of non-invasive devices currently in clinical studies needs regulatory consulting for approval and marketing of the devices. ( read more )..... |
Closed |
| 06-0030 |
Medical Device Training Provider needed for Qualification and Validation Training in Dominican Republic. Course must be given in spanish language, in Santo Domingo, Dominican Republic, Date: March 15 ( read more )..... |
Closed |
| 06-0029 |
Medical Device Manufacturer needs former FDA regulatory consultant for consulting on FDA 510(k). Consultant should have microbiology and Human factors engineering expertise for consulting on 510(k)wh ( read more )..... |
Closed |
| 06-0025 |
US FDA medical device consultant needed for evaluation of FDA registration and approval filing requirements for in-vitro diagnostic whole blood testing kit for clotting time. The kit contains 3 diffe ( read more )..... |
Closed |
| 06-0013 |
US medical device manufacturer needs regulatory medical device consultant for registering a medical device in Brazil. This product has been classified as a cosmetic, drug, Class I medical device, and ( read more )..... |
Closed |
| 06-0006 |
"US Medical Device Manufaturer needs quality consultant for assesment of Quality System to US Medical Device QSR especially in Design Controls. Consultant must interpret and be fluent in Chinese" ( read more )..... |
Closed |
| 06-0005 |
US medical device executive is interested in the regulatory requirements for conducting an active implantable medical device clinical trial in India. ( read more )..... |
Closed |
| 06-0003 |
US FDA Medical Device Consultant needed for FDA approval for a low level laser ( read more )..... |
Closed |
| 06-0002 |
Regulatory Consultant needed for Project Manager for Medical Device PMA application and study compliance" ( read more )..... |
Closed |
| 06-0001 |
Experienced US FDA Medical Device Consulant needed for filing Medical Device 510(K) including collecting related information, pick SE predictive device, and are experieced in geting approval from FDA ( read more )..... |
Closed |
| 05-0060 |
Medical Device Regulatory Consultant needed for preparing US FDA PMA for combination device for orthopedics, a spine fusion medical device with growth factors " ( read more )..... |
Closed |
| 05-0052 |
Medical Device Auditors needed for FDA mock inspection to assess compliance to the Quality System Regulation, including 21 CFR part 11 (were applicable). Mid-January 2006 ( read more )..... |
Closed |
| 05-0035 |
Ireland Consulting Firm needed to provide EU Medical Device Regulatory Training "" ( read more )..... |
Closed |
| 05-0034 |
Quality Consulting firm needed to implement FDA QSR quality system in 4 yr old startup company that has draft quality manual and a few SOPs."" ( read more )..... |
Closed |
| 05-0030 |
Biologicals regulatory consultants needed for registering our processed human tissue (for therapeutic use in humans) in the EU, Japan, Switzerland, Australia, and Korea. Because the hTEP regs are not ( read more )..... |
Closed |
| 05-0018 |
EU Medical Device Regulatory Consultant needed for consulting on EU registration submissions of wound healing gel as medical device in Europe."" ( read more )..... |
Closed |
| 05-0016 |
Quality consultant needed for auditing quality system for combination product (a drug eluting stent) compliance" ( read more )..... |
Closed |
| 05-0004 |
FDA Medical Device Regulatory Consultants needed for FDA PMA or 510K protocol approvals for latex male and female condoms. ( read more )..... |
Closed |
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For more information on Medical Devices consulting services, please call 1-403-770-1994 or email Global Regulatory
| Global Regulatory .com can assist your company in finding Regulatory Consultants for legal and regulatory services such as submissions, certifications, licensing, quality systems, technical writing, importing / exporting, expert witnesses, audits, consulting, scientific reviews, designated agents, compliance, validation, qualification, training, etc in industries such as: |
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