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