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Quality & Certifications

Absolute Quality Standards

Focused exclusively on medical manufacturing for more than 45 years, Donatelle makes products – many of which are implantable and lifesaving – with a single-minded, uncompromising focus on quality.

From design through delivery, our quality assurance processes utilize ISO-9001 and ISO-13485 certified systems. As an FDA registered contract manufacturer, we also follow the Quality Systems Regulations (QSR) of the FDA. 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.

Donatelle’s 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.