The Medical Devices Introductory Course 2020

Some new requirements in 2016 version

• See ISO 13485: 2016, Annex A (Comparison of contents of ISO 13485: 2003 and ISO 13485: 2016) • The Medical Device File (4.2.3 - corresponds to FDA’s Device Master File) • Design Transfer (7.3.8) • The Design and Development File (7.3.10 – corresponds to FDA’s Device History File) • The feedback process includes production and post-production feedback, not just complaint handling (8.2.1). • Information gathered in the feedback process is an input into the risk management process (8.2.1)

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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The benefits of a QMS

• Controls your processes • Provides consistency and repeatability • Monitors your performance • Provides a basis for improvement • Provides an effective management tool • Meets the expectations of your customers • Satisfies the applicable regulations

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

22