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QUALITY ASSURANCE

Medical devices and equipment need to be of exceptional quality and safety to bring health benefits without harming patients, health care workers or the general public. Compliant with FDA guidelines, we know how manage the hundreds of tiny details that make complex, safety-critical software projects succeed. Our extensive experience can guide you through the process for FDA 510(k), 21 CFR Part 11 and other regulated standards (FMEA, ISO 13485), as well as assist in certification and compatibility testing.

Links of Interest
	Information on Releasable 510(k)s