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Legal, Clinical & Regulatory

May 510(k) Review: New Players in SI Joint Fusion, Hip Recon

Of 56 products gaining clearance under FDA's Orthopedic Panel in May, we highlight the following four: a locking plate, next-gen meniscus repair implant, SI joint fusion device and new total hip.

Device Recalls: Prepare for the Unexpected to Minimize Operational and Fiscal Damage

While no company expects to undergo a FDA recall, preparatory steps can decrease the costly and lengthy process of removing product from the market. Begin by knowing the leading causes of recalls.

Don't Treat Your FDA Inspection Like an ISO Audit

Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each other with respect to medical device manufacturing and design quality systems. Despite the similarities, it is the interpretation and the approach of the investigator or the auditor that makes the experience very different.