60 mins

China Food and Drug Administration’s (CFDA’s) – GMP for Medical Devices

EU Medical Device Regulation (EU MDR) – Chapters 1 to 5

EU Medical Device Regulation (EU MDR) – Introduction

ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)

ISO 13485:2016 Product Realization (Chapter 7 – Part A)

Computer System Validation – Requirements: The Basis for Validation

Computer System Validation – The Regulated Software Life Cycle

21 CFR Part 820 Subpart I – Nonconforming Products

How to Write an Effective Equipment User Requirement Specification (URS)

21 CFR Part 820 Subpart F – Identification and Traceability