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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The European Commission’s Medical Device Coordination Group (MDCG) has adopted a definition for “hybrid audits” that offers notified...
While the total number of the most serious medical device recalls in the US has declined in recent years, the number of recall event...
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
The US Food and Drug Administration (FDA) warned Indian generic drugmaker Glenmark Pharmaceuticals Limited for several good manufact...
In its review, Medsafe’s committee considered TGA’s rationale and the evidence behind the decision. The review also looked at regula...
08 Dec 2022
08 Dec 2022 | Excelsior,USA