Global Medical Device Regulatory Updates

Global Medical Device Regulatory Updates

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About the Global Medical Device Regulatory Updates Group

Group is intended to share noteworthy updates on changes to medical device and IVD regulations worldwide, with a focus on the USA, Europe, Japan, China, Brazil, Canada,... more »
Group is intended to share noteworthy updates on changes to medical device and IVD regulations worldwide, with a focus on the USA, Europe, Japan, China, Brazil, Canada, Mexico, India, South Korea and Russia. Areas of focus include:

REGULATORY COMPLIANCE
> US FDA 510(k) process
> European Medical Devices Directive (MDD 93/42/EEC) and CE Marking
> EU Technical Files/Design Dossiers
> Clinical data
> Japanese PMDA submissions
> Medical device reimbursement
> Medical device labeling
> Risk management
> Much more...

QUALITY SYSTEM REGULATIONS
> ISO 13485
> US FDA Quality Systems Regulation (21 CFR Part 820)
> Japan Ordinance #169
> Brazil GMP
> Plus other global QMS regulations « less

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About this Group

  • Created: April 22, 2010
  • Type: Professional Group
  • Members: 6,004
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