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About us

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Who we are?

We’re a consulting firm specializing in regulatory compliance including new European Union MDR, quality engineering, and product (510k, PMA and DeNovo) submissions for the medical device industries.

Our headquarters is in Chicago, Illinois.

Meet Our Team

Donna Djinovich, MBA, RAC

Founder & CEO

Summary of qualifications
  • Regulatory and Quality professional with over 20 years of experience with extensive skills in Global Medical Device submissions, including FDA 510k/PMA/DeNovo premarketing approvals and CE Mark; Complete Quality System Development encompassing ISO 9001, FDA QS 820, ISO 13485; Team Building; Regulatory Agency Interactions; General Regulatory Compliance including MDD/MDR compliance.
  • Extensive QA/RA experience in small start-ups, midsize, large, public and private, as well as fortune 500 medical device and pharmaceutical companies such as Abbott and Baxter.