I agree Lena! This positions the industry well for the FDA to follow through with their agenda published in 2018 (
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201804&RIN=0910-AH99) and works to harmonize quality mangement system requirements before the end of the year.
#Medical Devices #Quality, #ISO13485, #QSR
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Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States
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Original Message:
Sent: 03-Sep-2019 11:33
From: Lena Cordie-Bancroft
Subject: AAMI TIR 102 - Now Published!
AAMI TIR102 - 'U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems' has been published and is available for purchase!
This is an excellent tool to help you align the FDA QS Regulations and ISO 13485 requirements in your QMS. It was an interesting project to work on!
https://my.aami.org/store/detail.aspx?id=TIR102-PDF
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Lena Cordie-Bancroft
Victoria MN
United States
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