Guidance through complex regulations so your business stays compliant with minimal risk

Certified auditing services in the Pacific Northwest for software, medical devices, and more.

A smiling man with long, wavy hair, wearing a professional navy shirt, and floral tie, standing in front of a wooden background.

Alex Villella

Partner In Your Success

I graduated from University of Washington - Seattle with a degree in Biochemistry. I worked in design and development for active medical devices eventually performing Internal Audits to CLIA and ISO AS9120B. I then worked for the British Standards Institute leading full quality management audits to a variety of medical device standards and regulations. Through my work experience I have helped organizations small and large. I believe in helping smaller organizations achieve goals in the medical space bringing new much needed technology to the market. Whether its regulatory assessments or guidance on the next external audits I am here for your next certification efforts.

Certified regulatory and quality services no matter the medical device

  • ISO 9001

  • ISO 13485

  • ISO 14971

  • EU MDR

  • EU IVDR

  • UK MDR

  • MDSAP