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Grace Fu Palma, founder and CEO of Boston-based China Med Device, a firm specializing in commercialization and funding for medtech companies entering China, explains how medtech companies can use a new guideline from the China FDA to help secure fast track approvals for innovative medical devices.Read More
Zimmer Biomet’s Warsaw, Ind., medical device facility was hit with a massive, 58-page Form 483 arising from an inspection carried out from September to November of 2016. Read More
Best Medical Canada landed a Form 483 for not establishing adequate complaint procedures or ensuring that its devices conformed to specifications. Read More
FDA inspectors hit Covidien with a Form 483 for inadequate complaint evaluation and process control procedures, as well as failure to ensure appropriate design and installation of manufacturing equipment. Read More
Nomax received a warning letter for failing to evaluate complaints, document corrective and preventive actions, and committing other violations. Read More
Zimmer Biomet’s Warsaw, Ind., medical device facility was hit with a massive, 58-page Form 483 arising from an inspection carried out from September to November of 2016. Read More