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