About Us Medical Markets Capabilities Case Studies Expert Insights Careers News Contact Us Medical device process validation Confidence and results Home / Capabilities / Process validation Along with a commitment to absolute quality standards, we offer rigorous process validation, so you can be confident your medical devices and components are defensibly accurate. We are: FDA registered as a contract manufacturer 21 CFR 820 compliant ISO 9001 and ISO 13485 certified Proficient in Class I, II and III devices We use empirical data backed with sound statistical analysis to understand and control all sources of variation that can affect product quality. This enables us to we prove out and provide documented evidence your product will meet specifications and quality attributes. And we provide all the documentation needed for your design and device history files, and device master record. Our team of specialists includes certified packaging professionals and quality engineers. Among other areas, they’re experienced in medical device process validation methodologies, Geometric Dimensioning and Tolerancing (GD&T) and scientific process development. Specializing in medical device process validation for: Cardiac rhythm devices Diagnostic devices Drug delivery systems Neuromodulation devices Ophthalmic devices Orthopedic devices Surgical devices Vascular devices And more! 501 County Road E2 Extension New Brighton, MN 55112 Phone: +1-651-633-4200 Fax: +1-651-633-5486 ©2021 Donatelle. All rights reserved. Donatelle and the Donatelle logo are registered trademarks of Donatelle Plastics Incorporated. | Privacy Policy