The Medical Devices Introductory Course 2020

What you will need for EN ISO 13485.4

You will need processes/SOPs for: The entire QMS Control of documents Control of records

Control of outsourced processes Data security

You will need:

A quality manual Process flow charts A “Medical device file” for each medical device

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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EN ISO 13485.5: Management Responsibility

5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management review

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

12