The key is to keep quality high and risk low.
Make sure your 510(k) submissions pass with flying colors. Explore the latest regulations impacting bacterial endotoxin testing.
An important yet often mysterious part of validation.
You can’t just validate processes—you have to monitor them, too.
Assessing the Manufacturing Readiness Level of your new product can help identify risks and opportunities to cut time to market.
Process validation is a mission-critical activity. Medical device manufacturers must ensure all processes are either verified or validated. This week’s Devine Guidance discusses compliance with section 820.75—process validation.