Donatelle™ Medical Manufacturing Quality Assurance

We never forget it’s your reputation and the quality of a patient’s life that may be on the line.

At Donatelle, we focus exclusively on medical manufacturing and have been serving the medical community for more than 40 years. Many of the devices we are involved with making are life-saving and implantable, with the strictest of quality requirements.  Donatelle works to meet all quality standards and give medical manufacturing quality with assurance. 

From design through shipment, our 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. That's confidence you can pass on to the patient.

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.

FDA Registered and ISO Certified

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