About Us Medical Markets Capabilities Case Studies Expert Insights Careers News Contact Us Quality and certifications Home / About Us / Quality and certifications Quality and Certifications From design through delivery, our quality assurance processes utilize ISO-9001 and ISO-13485 certified systems. As an FDA-registered contract manufacturer adhering to Good Manufacturing Practices (GMP), we also follow the Administration’s Quality Systems Regulations (QSR). During manufacturing of your device components and assemblies, our process control systems monitor all key process variables, incorporating real-time statistical control (SPC) to help ensure part consistency. Our quality policy Donatelle is committed to meeting our customers’ expectations by providing the highest achievable quality of products and service through continual improvement and maintaining effectiveness at all levels of our Quality Management System. More about us The Donatelle difference Our values Quality and certifications 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

About Us Medical Markets Capabilities Case Studies Expert Insights Careers News Contact Us News Home / News New: Podcast from Medtronic Sep 27, 2021 Donatelle is a proud sponsor of the DeviceTalks podcast featuring Medtronic’s Mike Marinaro, President, Cardiac Rhythm ... read more NEW: Case study Aug 27, 2021 Learn how Donatelle’s vertically integrated capabilities and pure expertise helped produce a specially designed micro seal for an read more Download our new white paper Aug 23, 2021 Learn why taking full advantage of cutting-edge bioresorbable materials for medical devices and components requires an understanding of read more Check out our new case study Aug 23, 2021 Learn how we pushed the limits of micro manufacturing to help an OEM improve their cardiovascular device. read more Join us at MD&M West Jul 14, 2021 Learn more about how you can count on our next-gen technology and treasured know-how – including micro-MIM and bioresorbable – to help ... read more Older Entries Specializing in medical device product design and development for: Cardiac rhythm devices Diagnostics 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