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.

Bring your Class I, Class II and Class III medical device products to market with confidence. Contact us!

TUV SUD ISO 9001 logo
TUV SUD ISO 9001 logo
501 County Road E2 Extension
New Brighton, MN 55112
Phone: +1-651-633-4200
Fax: +1-651-633-5486