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Quality & Certifications

Vital Standards

When it comes to meeting exacting standards for your products, it’s not just our business that’s on the line. It’s your reputation. And it’s patients’ lives.

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 shipment, our quality assurance processes utilize ISO-9001:2008 and ISO-13485:2003 certified systems. As an FDA registered facility, we also follow the Quality Systems Regulations (QSR) of the FDA. During manufacturing of your device components and assemblies, our process control systems are able to monitor all key process variables, incorporating real-time statistical control (SPC) to 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.