Sam’s List of FDA Registered Contract Manufacturers & Sterilizers in SF Bay Area

 Think global, buy local…and local for me is the San Francisco, California USA area.

Here is my list of San Francisco Bay Area FDA Registered Medical Device Contract Manufacturers and Sterilizers.

This list is focused on finished device manufacturers and contract sterilizers who are registered as such with FDA, and are located in the 9 counties in the SF Bay Area.

As I update the list with new information I receive, the same link should still work.
The list has a footer with my contact info and the last revision date.

Any comments, questions or suggestions are very welcome.

There were a few firms recommended to me for the list that are not included since I was not able to verify FDA registration either via the FDA search or by directly contacting the firm.  Interestingly, not all firms who are FDA registered appear when you try to search for them here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

 

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.

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