Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

Our device performs as intended as we have only 1% of complaints

Absence of evidence is not evidence of absence.

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The Organisation for Professionals in Regulatory Affairs

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The Clinical Evaluation Process; MedDev 2.7/1 Clause 6.3

Stage 0: Plan and Scope Section 7; A3

Stage 4: Clinical evaluation report (incl PMS/PMCF plan) Section 11; A9-A10

Stage 1: Identify data Section 8; A4-A5

MDR Annex XIV Part A describes a similar process

Stage 3: Analyse data Section 10; A7 A8

Stage 2: Appraise data Section 9; A6

The Organisation for Professionals in Regulatory Affairs

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