Sam Lazzara's Medical Device Quality Central Blog

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Think global, buy local...and local for me is the San Francisco, California USA area. Here is a link to a list I compiled for SF 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 f

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Here is a high level task list intended for medical device labelers who want to implement FDA requirements for Unique Device Identification. Check out this blog page for general information related to UDI. 1.      Determine FDA 21 CFR requirements applicable to your devices. 2.      Perform gap analysis between FDA requirements and current quality system. 3.      Create Quality Plan for UDI implementation. 4.      Select FDA-accredited issuing agency. Become member and obtain company prefix. 5.      Select and procure label printing system (printer and software). Same goes for device marking system if required. 6.      Design and procure package label stock(s) with primary printing. 7.      Choose barcode style to be employed on package labels and/or device itself. 8.      Develop secondary/production label printing “artwork” using software.Same goes fo

The ASQ Biomedical Division asked me to write this article for the Biofeedback newsletter.  Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net

The ASQ Biomedical Division asked me to write an article for the Biofeedback newsletter. For a PDF version of my article, go here . Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net