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.
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