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EU-IVDR Implementation 2020 - What You Need to Know: Auditing EU-MDR and EU-IVDR Implementation



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Topics/Call fo Papers

With one extension already granted, any organization selling devices in the region now need to be ready for the shift by May 2021. There’s little time to spare to get your processes up to par — but WCS can help get you there.
Internal Audit Programming: ISO 19011:2018 and 13485:2016
Conformity Assessment Paths and Device-Specific Areas: QMS and RMS; Annex I, II, and III
The Internal Audit Program
ISO 19011:2018
ISO 13485:2016
Planning, conducting and reporting
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices,

Last modified: 2020-10-14 18:48:18