Medical devices play an important role in modern healthcare, from diagnostic equipment and monitoring systems to implants and surgical instruments. Before a new medical device reaches the market, manufacturers need reliable clinical evidence to demonstrate its safety, performance, and suitability for its intended purpose. Clinical evidence does not necessarily stop once a device receives market authorization. Continued monitoring and evaluation are also important throughout the product lifecycle. Two important activities…
The medical device and in vitro diagnostic (IVD) industry operates in a highly regulated environment where patient safety, product effectiveness, and continuous monitoring are essential. With the implementation of the In Vitro Diagnostic Regulation (IVDR), manufacturers must follow strict requirements to demonstrate the safety and performance of their diagnostic devices. Two critical elements in this regulatory framework are IVDR Performance Evaluation and Post Market Clinical Follow Up. These processes help manufacturers maintain compliance…
