Certified Compliance Solutions

Medical Equipment ManufacturingUnited States2-10 Employees

A recognized industry leader for over 20 years in regulatory and quality compliance for medical devices, pharmaceuticals, and biotech. We have assisted over 200 clients in meeting QSR and FDA compliance.  We guarantee our work relative to FDA regulations and ISO standards. Our training is referenced in FDA's software validation guidelines. 

We are your full service solution to quality management, design control, software validation, and software development. We provide support from custom medical device development to independent testing and 510(k) submission services. Our company has been hired by the FDA Head-quarters to provide software training for FDA investigators! Our experience and expertise ensure that you not only receive quality services but also full compliance with current FDA and European Community regulations. We take the mystery out of regulatory requirements for medical devices.

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