Additive manufacturing is a relatively new technology within the medical device industry (primarily orthopedic and like spaces), with some unknowns. Partnering with a supplier that understands the significance and differences of holding an ISO 13485 certification, as well being an FDA-registered manufacturer is important. Adding the complexity of being an additive manufacturer for traditional medical devices has opened questions and regulatory scrutiny — specifically around having validated processes. Understanding how to navigate, add value and win contracts by being informed about these is critical to your success. This presentation will cover an in-depth analysis of each of these three criteria and an understanding of the necessity of each.
- Understand the requirements and differences among ISO 13485, being FDA registered (manufacturer), and having validated systems
- Evaluate your current systems and implement a plan to become compliant with all three systems