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MDR and IVDR Regulatory Path Flowchart

Adnan Ashfaq

QA/RA MDR/IVDR & Validation Consultant at Simplimedica Ltd

发布日期: 2018年4月15日

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A few weeks ago I was asked to write about a concept to market flow diagram of developing a new medical device. These flowcharts above describe the phases of a device development with the relevant Articles and Annexes from the MDR and IVDR. These will be available as we discuss with device developers at the upcoming Med Tech Expo in Coventry on 25th April - 26th April 2018 https://www.med-techexpo.com/exhibitors/pharmi-med-ltd?&azletter=P&searchgroup=libraryentry-exhibitors

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