Regulatory

Support services for FDA-regulated small businesses

Innovative Synergies offers professional support services to companies that design, develop and produce medical software and devices.

We have many years of experience in ensuring compliance with the FDA’s Quality System Regulation, Part 820 of Title 21 of the Code of Federal Regulations, from an internal regulatory affairs and quality perspective and external auditing and consulting.

We specialize in working with small- to medium-size manufacturers, and our experience includes practical expertise in the establishment and maintenance of an FDA-compliant quality system, to include the writing and implementation of compliant policies and procedures.

In addition, we can work with you to write and prepare a successful pre-market approval 510(k) submission to gain FDA clearance to market your medical device in the United States.

Contact us today for more information, or to discuss your project.