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Find Medical Device regulatory consultants for all your Medical Device consulting, audits and training such as regulatory submissions, regulatory compliance, advisory meetings, validation, regulatory actions, warning letters, import detentions, exporting, importing, seizures, non-approvals, FDA, Good Manufacturing Practices in countries such as the USA, Canada, Mexico, European Union, United Kingdom, Ireland, China, Japan, Australia, etc.

Medical Device Requests for Proposals

Global Regulatory.com has received the following incoming Medical Device Requests which need to be fulfilled ! These Medical Device Requests are received from a variety of sources ranging from start-up companies to large, multinational corporations actively seeking companies to perform their Medical Device services. If your company receives requests that it can not fulfill, please refer them to us! If you have questions, please e-mail us or call 403-770-1994 .

Incoming Medical Device Requests
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Medical Device request description
status
( read more ).....
14-0011 FDA Validation Consultant needed for FDA Process validation for plastics injection moulding and extrusion. Pragmatic experience with FDA current requirements and expectations for process validation of ( read more ).....
hrghrgh ( read more ).....
14-0001 South America Regulatory Consultant needed for Regulatory Filing requirements in different Latin American countries ( read more ).....
13-00035 Freelance China and UAE regulatory consultants to register medical devices in China and UAE. ( read more ).....
13-00029 INDIVIDUAL FREELANCE ASIA Medical Device consultant in South East Asia needed for registration of medical devices, able to act as local representative also. ( read more ).....
job in reputed medical device company ( read more ).....
13-0015 Medical Device Consultant needed for UK and USDA licenses and submissions for Poultry diagnostic tests licenced by USDA as is our UK and US facilities. We need to maintain this status and update pape ( read more ).....
13-0001 Swiss medical device manufacturer needs consultant to register a combination product in Russia. Registration Scenario: In Europe a disposable, non-reusable, multi-use, pre-filled pen will be re ( read more )..... Closed
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 )..... Closed
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 ).....
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 ).....
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 ).....
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 ).....
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 ).....
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 ).....
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 ).....
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 ).....
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 ).....
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 ).....
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 ).....
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 ).....
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
Looking for consultant with biotech drug/device combination product registration expirience in Brazil and Mexico who can assist company with obtaining reg approval - Classified as a Medical Device in ( 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
10-00165 Canada Regulatory Consultant needed for Consulting for all Canadian compliance issues such as Health Canada, Hazardous Products Act, Bill-C6 and more. Products include baby bottles, pacifiers, water-f ( 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 ยง 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
09-0121 Need: A two-day audit (1 auditor needed for both days). Combination of Team Biologics style and QSIT Medical Device style audit. Focus on CAPA systems, Complaints and DAE, Document Control, Training, ( 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
06-0164 Independent consultant needed with at least 5 years experience in software/computer systems validation in a GMP environment, preferably medical device manufacturing. ( 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
05-0057 ""Large Medical Device Company seeking a service provider for the selection, establishment, and management of a DSMB for a cardiovascular medical device clinical trials study."" ( 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

For more information on Medical Device services, please call 1-403-770-1994 or email us



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