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Conformity assessment process and documentation requirements for submissions
Device and Drug Combinations in EU.
Introduction to BSI Medicinal team.
MDCG 2020-12 - MDR Conformity Assessment Process.
Competent Authority Assessment & Documentation Requirements.
Hear from Theresa Jeary as she explains more about the conformity assessment process for medical devices containing an ancillary medicinal substance.
Global Head - Medicinal & Biologics, BSI.
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