Medical Device Testing: The New Rules

    Key Takeaways Regulatory demands for medical device testing are rising across the FDA and the EU MDR. Disconnected vendors increase the risk of delays, errors, and noncompliance. Core areas like sterility, shelf life, and biocompatibility now face tighter scrutiny. Centralized testing reduces risk, accelerates launch, and boosts submission success. Millstone’s ISO 17025 lab…