The Medical Devices Introductory Course 2020

What you will need for EN ISO 13485.7

You will need processes/SOPs for: Design and development

Purchasing and supplier evaluation Risk management Manufacturing processes Packaging, labelling, sterilisation Product identification and traceability Calibration of measuring devices

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8.2 Monitoring & measurement 8.2.1 Feedback (early warning of quality problems) 8.2.2 Complaint handling 8.2.3 Reporting to regulatory authorities 8.2.4 Internal audit (to verify the effectiveness of the QMS) EN ISO 13485.8: Measurement, Analysis and Improvement

8.2.5 Monitoring & measurement of processes (yield) 8.2.6 Monitoring & measurement of product (inspection) 8.3 Control of nonconforming product (segregation, rework, concession, recall) 8.4 Analysis of data 8.5 Improvement

8.5.2 Corrective action (to prevent recurrence) 8.5.3 Preventive action (to prevent occurrence)

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The Organisation for Professionals in Regulatory Affairs

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