Verification and Lot Release Testing of AM-Produced Medical Devices

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.

Whitepaper outline

• Background
• Material considerations for AM-produced implantable medical devices
• Validating AM processes
• Deficiencies in regulatory submissions for AM-produced implantable medical devices
• State-of-the-art and industry standards specific to AM-produced implantable medical devices
• Key takeaways
• Conclusion