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Medical Devices

Need to find former US FDA medical device consultants to write FDA PMA, IDE, or 510k sumissions? Need to find medical device consultants to ensure compliance to the IVD Directive or FDA QSR ? Or simply want to save time calling multiple medical devices consulting companies ? Save time and money. Simply, use Global Regulatory .com 's convenient on-line form to Submit Medical Devices Consulting Requests in one centralized location at no charge!
Medical Device Consultants

Global Regulatory .com can assist your in-vitro diagnostic and medical device company, manufacturer or distributor in finding Medical Device Consultants and Attorneys specializing in In-Vitro Diagnostics and Medical Devices for all your Medical Device consulting projects such as :

  • Regulatory Consulting Services
    • Regulatory Strategies
    • Regulatory Structure
    • Regulatory Personnel
    • Regulatory Affairs Staffing, Support and Management
  • Government Liasons and Meetings
    • US Food and Drug Administration (FDA) CDRH Advisory and Compliance Meetings
    • Health Canada Meetings
    • European Union EMEC Meetings
  • Medical Device Regulatory Submissions
    • US FDA Medical Device Premarket Approval (PMA) Applications
    • US FDA Medical Device Premarket Notification 510(k)s Applications
    • US FDA Medical Device Investigational Device Exemptions (IDE)
    • European Union Common Technical Files (CTD)
  • Quality Assurance and Compliance
    • Standard Operating Procedures(SOP) Development and Review
    • Quality Assurance Staffing and Management
  • Audits
    • QSIT / Good Manufacturing (GMP) Audits
    • ISO Audits
    • Good Laboratory Practices (GLP) Audits
  • Training
    • QSR Training
    • ISO Training
    • Good Laboratory Practices (GLP) Training
    • Good Manufacturing Practices (GMP) Training
    • Good Clinical Practices (GCP) Training
    • Validation Training
  • Medical Device Labeling and Promotional Materials
  • Qualification and Validation
    • Process Validation
    • Cleaning Validation
    • Software Validation
    • CFR Part 11
  • Clinical Consulting Services
    • Preclinical and Clinical Trial Design
    • Clinical Trial Monitoring
    • Evaluation of Clinical Data
  • CE Maring k
  • European Union Authorized Representative
  • United States Agent
  • European Union In-Vitro Diagnostic (IVD) Directive
  • European Union Medical Device Directive (MDD)

Global Regulatory .com can assist your medical device and in-vitro diagnostic company, manufacturer, distributor, in finding Medical Device Consultants for projects in many different medical areas and products such as, pediatric medical devices, in-vitro diagnostic devices, sterile implantable medical devices, pacemakers, stents, artifical hearts, knee replacements, hip replacements, physical medicine devices, radiology devices, nuclear medicine devices, CAT scanning machines, PET scanning machines, disposable medical devices, contact lenses, hearing aids, cochlear implants, blood glucose meters, pregnancy test kits, latex gloves, breast implants, surgical gloves, condoms, intraocular lenses, IV, needles, blood bags, reproductive devices, nebulizers, mammography machines, single-use medical devices, electrical medical devices, biological medical devices, X-Ray , wireless medical telemetry,lasers, anesthesiology medical devices, surgical devices, sutures, angioplaty devices, apnea monitors, catheters, defibrillators, aneurysm clips, dressings, cardiovascular medical devices, ear, nose and throat medical devices, orthopedic medical devices, microbiology medical devices, opthalmic medical devices, pathology medical devices, toxicology medical devices, dental medical devices, immunology medical devices, neurology medical devices, surgery medical devices, plastic medical devices, medical gases, reusable medical devices, etc.

Global Regulatory .com can assist your company, manufacturer, developer, research facility, academic institution, government agency or organization in finding Medical Devices Consultants for projects in many areas such as the New York, New Jersey, Minneapolis, Minnesota, Dallas, San Antonio, Houston, Texas, San Diego, San Francisco, Los Angeles, California, Seattle, Washington, Miami, Ft. Lauderdale, Florida, Raleigh, Durham, North Carolina, Virginia, Boston, Massachusetts, Maryland, Chicago, Illinois, Puerto Rico, USA, Vancouver, British Columbia, Toronto, Edmonton, Canada, European Union (EU), Paris, France, Madrid, Spain, Munich, Germany, Brazil, Hong Kong, Taiwan, Dublin, Ireland, Brazil, Venezuela, Mexico, South America, Middle East, Asia, London, England, Great Britain, United Kingdom, Tokyo, Japan, Israel, Australia, New Zealand, China, Pacific Rim, Africa, Russia, Eastern Europe, etc.

Need to find Medical Devices Consultants with specific requirements ? Global Regulatory .com's convenient on-line Medical Devices Consulting Requests form allows you to specify requirements for your Medical Devices and In-Vitro Diagnostics, consulting, auditing and training needs such as location, language, licenses, certifications, organization membership and experience such as former FDA, RAPS RAC certified, Spanish, French, German, Professional Engineers, PhD, MD, etc.

Or find other Consultants to perform other projects, call us at 403-770-1994 or email us.

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International Regulatory News

UKAS Assessment Programme for Accreditation for Certification of Green Deal Advisors and Installers
2011-12-12 00:00:00
The deadline for applications to participate in the UKAS programme for the accreditation of certification bodies to certify Green Deal Advisors and Installers expired on 30 September 2011. UKAS received 33 applications from organisations who wish to ... 

Trident catheter valve - Model Number: 380851
2011-12-12 00:00:00
The Therapeutic Goods Administration (TGA) advises that certain lots of the Trident Catheter Valve (Australian Register of Therapeutic Goods (ARTG) number 107139) are being recalled. The Trident Catheter Valve is used for connecting a urinary cath... 

TGA reforms: a blueprint for TGA's future
2011-12-08 00:00:00
Government to improve regulation of therapeutic goods media release, The Hon Catherine King MP 8 December 2011 The Australian Government has released its response to several major reviews of therapeutic goods regulation that have been undert... 

Respirtek ISO 17025 Business Management Improvements
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel... 

Respirtek, Inc. ISO 17025 Accreditation Announcement
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel... 

UKAS Accreditation for Inspection of Fairground and Amusement Park Devices - Pilot Project Update
2011-11-11 00:00:00
The first pilot assessment by UKAS of an inspection body involved in inspection of fairground and amusement park devices is now under way. A pre- assessment of Jacobs Engineering (UK) Ltd, Ashton Lane, Manchester was conducted by UKAS recently, wher... 

ACCREDITATION MATTERS ISSUE 8 NOW AVAILABLE
2011-11-08 00:00:00
A new edition of Accreditation Matters, UKAS' newsletter for the public sector, has been released. Issue 8 gives information about the appointment of UKAS as the accreditation body for the Green Deal, the Government's flagship programme for improving... 

Nova now provides Sterility and Endotoxin Testing for the Radiopharmaceutical Industry
2011-11-01 00:00:00
Radiopharmaceutical sterility testing is required during the sterilization validation process as well as for routine product release testing. USP <71> sterility testing is an official test to determine sterility of a product. Nova's understanding of ... 

FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation
2011-10-26 00:00:00
The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and Georgeto... 


2011-10-26 00:00:00
FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tabl... 

FDA approves Onfi to treat severe type of seizures
2011-10-26 00:00:00
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended t... 

Illinois warehouse Prevents unsafe food distribution from rodent-infested facility
2011-10-19 00:00:00
FDA: U.S. Marshals seize food products at U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warr... 

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