Change Management, especially related to a medical device’s design, is one of the most commonly cited issues in FDA 483s and Warning Letters. Unfortunately, change is constant in the medical device industry, so it’s imperative to learn how to effectively evaluate change and incorporate findings into biocompatibility testing and documentation. In this webinar, industry experts from Nelson Labs will teach you how to:
• Accurately identify change
• Evaluate change’s impact on biocompatibility and testing
• Effectively and proactively predict and document rational of changes
• Remain compliant when changes inevitably occur