Medical Device Vigilance

Device manufacturers have a responsibility to implement an effective post-marketing surveillance system to ensure early identification of problems or risks and report these events to competent authorities and the Medical Device vigilance module of PvEdge helps them doing the same. To ensure the safety and effectiveness of medical devices and avoid the financial and legal liabilities associated with a device recall, medical device manufacturers began to assess and understand device risk during the product design stage of medical device development.

Medical device post-market surveillance is not only regulatory driven but should also be considered as a good business practice. It helps the manufacturer to obtain an understanding of the performance of the device once placed on the market and provides continuous feedback that enables manufacturers to maintain a high standard of product quality and consumer satisfaction. It also helps to minimize exposure arising from incidents through effective warning and product recall processes and procedures.