The advancement of reusable medical devices has changed the industry over the years and the requirements for validating reprocessing instructions have changed with it. It can be difficult to navigate these changes and ensure that the reprocessing validations meet the current industry standards and expectations. An understanding of the best practices when validating reusable medical devices will aid in navigating medical device manufacturers through these changes and challenges. The presentation will cover some of the best practices when validating the reprocessing instructions for reusable medical devices.
- Understanding which documents would play a key role in your reprocessing validation
- How to best design a reprocessing validation to avoid regulatory scrutiny
- Understanding new regulations regarding validations strategies for reusable medical devices