The Medical Devices Introductory Course 2020

• Plan : establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies • Do : implement the processes • Check : monitor and measure processes and product against policies, objectives and requirements for the product and report the results • Act : take actions to improve process performance ISO 13485 is based on Plan-Do-Check-Act methodology

Repeat cycle for “continuous improvement”

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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EN ISO 13485 2016 clauses (26 pages)

1. Scope 2. Normative References 3. Terms and Definitions

4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

8