Scrip Regulatory Affairs
Quality by Design - a status report
01 June 2011
Siegfried Schmitt
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NEWS
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- FDA report questions whether US rules can ensure quality of marketed medical devices
- Brand vs generic: the battle rages over EU anti-counterfeit 'safety features'
- EMA policy on allowing access to EudraVigilance data imminent
- GHTF proposes risk-based approach to rate non-conformities in device QMS audits
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ANALYSIS
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COMMENT
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