Medical implant devices produced using additive manufacturing (AM) represent one of the fastest-growing segments in the medical device industry. But the speed of that growth has also presented unique challenges regarding both validation and verification testing intended to demonstrate compliance with quality and regulatory requirements that address patient safety.
Although regulatory guidance documents exist, the primary guidance is nearly a decade old and translating those guidelines into practice can be a daunting task. This joint white paper between TÜV SÜD and Empirical Technologies will discuss these challenges, as well as provide real-life examples of regulatory issues facing medical device manufacturers using AM.
Middle East and Africa