Change is the one constant in life and that is absolutely the current climate in the medical device industry. This post-COVID19 era is riddled with supply chain roadblocks that medical device companies are working through on a daily basis. The options are typically finding a new material, a new supplier, and sometimes, both. The question that remains at the end of a device change is regarding device biocompatibility. In this webinar, we will go through case studies using a risk-based approach to determine the best data to gather to ensure that devices are still safe for the patient and remain compliant to the most recent ISO standards.
Highlights from the presentation will include:
- Case studies
- Application of ISO 10993-1
- Critical supplier information
- Risk-based approach to changes