The Medical Devices Introductory Course 2020

What you will need for EN ISO 13485.8

You will need processes/SOPs for:

In-coming, in-process and final inspection Complaint handling Internal audit Control of nonconforming product Analysis of data Corrective and preventive action (CAPA)

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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Other requirements

You will need processes/SOPs to comply with MDR and MDD requirements including: Interaction with your NB Vigilance (adverse event reporting) (8.2.3) Clinical evaluation (7.3.7)

Essential requirements Technical documentation Labelling (7.5.1) CE marking

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

20