Thanks for posting this important DRAFT, Dan. At least there is some progress towards Harmonized Standards for MDR and IVDR. This is a hopeful sign, but I'm sure much work needs to be done before we see a list of Harmonized Standards.
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 31-Oct-2020 14:20
From: Dan O'Leary
Subject: Draft Standardization Request
Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
is available at
https://ec.europa.eu/docsroom/documents/43584?locale=en
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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