Regulatory updates affecting medical device and IVD manufacturers
Have an interest in international regulatory and quality assurance issues? Subscribe to our periodic eJournal. See samples of past eJournal newsletters below:
- MAY 2008 - Emergo Group expands services to Japan and China
- MARCH 2008 - Proposed Changes to the GHTF Regulatory Auditing Guideline
- OCTOBER 2007 - FDA revises user fees for 2008-2012
- OCTOBER 2007 - Upcoming Changes to the European Medical Device Directive
- SEPTEMBER 2007 - Amendments to the European Medical Device Directives published.
- JUNE 2007 - Europe issues new guidance document on medical device post market surveillance and vigilance.
- APRIL 2007 - Hip, knee and shoulder reclassification
- FEBRUARY 2007 - Bulgaria and Romania admission to the EU and impact for medical device manufacturers.
- JANUARY 2007 - EU releases new guidance document for e-labeling
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