The medical device industry is no stranger to change. In fact, a medical device and its support system may undergo hundreds of changes throughout the duration of the product life cycle. From improved design, new suppliers, better processes, or supplier change notification, we are constantly dealing with the impact of change. Knowing how to properly evaluate and manage all areas that are impacted by a change is a critically important process for manufacturers to master.
In this free webinar, biocompatibility and risk subject matter expert, Thor Rollins from Nelson Laboratories will present proven ways in which manufacturers can evaluate whether biocompatibility testing and risk mitigations are necessary when making changes to a medical device. Learn how to evaluate possible safety impacts following any change that is made and how to effectively mitigate biocompatibility risks.
SPECIFICALLY THIS WEBINAR WILL COVER:
- Guidance on which changes would be considered impactful and which ones are low risk
- What procedures can be put into place to evaluate and deal with changes
- What information is needed before a change can be evaluated
- Planning the cheapest and easiest test system to accept the change
- Implications for your risk management processes
- Q&A session
WHO SHOULD ATTEND?
- Medical Device Executives
- Human Factors and UX Professionals
- Regulatory Affairs Professionals and Management
- Quality Professionals and Management
- Clinical Affairs Professionals and Management
- R&D Engineers and Management