When precision and compliance matter most, our clients turn to BAG.

A biotech innovator approached us with a critical need: validate terminal sterilization for a medical device under the strict requirements of EU MDR 2017/745. Our experts responded with a fully integrated solution—combining ISO 11135 sterilization validation, GMP-compliant documentation, and regulatory support tailored for Notified Body review.

From bioburden analysis to Sterilization Master File delivery, we handled every detail. Our QA and regulatory teams worked hand-in-hand with the client, ensuring compliance, clarity, and confidence at every step.
The result: MDR-compliant sterilization. Regulatory-ready documentation. And a client ready for market.