Founder Karen A. Iorio is a problem-solving, collaborative and business-minded Quality Assurance and Regulatory Affairs Executive with over 15 years of experience in the regulated medical device and medical device software industries.


About Karen

Developing Quality Systems and supporting continuous improvement initiatives to achieve compliance with global regulatory requirements including the FDA’s Quality System Regulation.

Our Services

"Karen quickly and accurately did an independent assessment of our QA program and put us in the correct direction. Her assistance was invaluable to us. I would be happy to recommend her at any time."

Testimonials