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Legal, Clinical & Regulatory

FDA Update: Final Guidance on Medical Device Reporting

FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is to detect and correct device problems in a timely manner.

A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens

Our global industry requires companies to develop harmonized postmarket surveillance systems that minimize inconsistencies in our understanding of product lifecycle risks.

One Answer to Your Postmarket Challenge: Planning

Planning goes a long way in moving from premarket to postmarket data collection. Vicki Anastasi, an OMTEC 2016 speaker, suggests the best way to start.