Module 14 2022

22/03/2022

GENERAL SAFETY & PERFORMANCE REQUIREMENTS (GSPR)

• Annex 1 of the MDR

• See attachment in your notes

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

33

GOOD DESIGN PRACTICE

Why are ISO standards so important? ● Internationally agreed standards that need to be followed for specific aspects of medical device design and control ● Some of the KEY STANDARDS: – ISO 13485: 2016 - QUALITY MANAGEMENT SYSTEMS – ISO 14971: 2019 - RISK MANAGEMENT – ISO 10993 series - BIOLOGICAL EVALUATION OF MEDICAL DEVICES – ISO 14155: 2011 - GCP – IEC/TR 80002 series and developing ISOs - MEDICAL DEVICE SOFTWARE – IEC 62366 series and associated ISOs: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES – ISO 16142-1: 2016/2017 – General and additional specific essential principles – IVD medical devices

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

34

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