With no relief in sight for supply chain issues and sterilization constraints, understanding the options associated with change has become an immediate need in industry. This 3-day webinar will identify considerations and challenges outlined in regulatory standards to allow for success in an agile environment. Our topics of focus include navigating Ethylene Oxide & Radiation Sterilization, Packaging, and Biocompatibility/Biosafety changes and addressing the expectations around managing changes.
Day 3: Biocompatibility/Biosafety: Evaluating the Impact of a Change
Abstract: Many medical device manufacturers find themselves needing to make small changes to the materials and processing of their devices. For example, switching suppliers of an equivalent plastic resin or changing manufacturing location while keeping materials and processing the same. This presentation will give hands-on examples of real changes we have dealt with recently and provide feedback on evaluation of biocompatibility and documentation in the design history file.
- How to decide the appropriate level of regulatory response to a change, is this internal documentation or a new 510(k)?
- The relationship between device changes and potential test outcomes
- Examples of recent devices changes and responses