Sam Lazzara's Medical Device Quality Central Blog

FDA UDI (DI+PI) FAQ, Sam Lazzara Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Related Posts Notified Body Short List  Notified Body Sleuthing Suggested Screening Questions - Will my QS lead auditor also be my lead Technical File (CE) project manager/reviewer? - Are any of your auditors contractors (vs. employees)? - Who will be my QS lead auditor? Can you provide their CV (or bio)? May I speak to him/her? - Who will be my CE Technical File lead auditor? Can you provide their CV (or bio)? May I speak to him/her? - Is your CE lead auditor a project manager who "subcontracts" the review of the various Tech File subjects, or do they personally perform the detailed technical reviews? If the former, who else is on the review team? - Who is our lead reviewer for clinical evaluation data? Employee/contractor? Practicing physician? Has enough time? What is their process? - Where do my auditors live? USA? Europe? Travel costs...

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 ...

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 sty...

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

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Link to Sam Lazzara's EN ISO 14971:2012 Flow Chart  Still trying to figure out what to do about EN ISO 14971:2012? The ASQ Biomedical Division just published an article I wrote called Risky Business - Demystifying EN ISO 14971:2012 . To view the article, go here . Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Summary EN ISO 14971:2012 became a European harmonized standard on August 30, 2012. The normative content is still in accordance with ISO 14791:2007. However, the relationship between ISO 14971 and the European Directives has changed as described in Annex ZA, ZB and ZC. Compliance with the normative clauses in ISO 14971 does not ensure conformity with the Essential Requirements (ERs) of the Directives. The Z Annexes list “content deviations” between ISO 14...