Intermediate

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

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

ISO 13485:2016 – Chapter 6: Resource Management

ISO 13485:2016 – Chapter 5: Management Responsibility

ISO 13485:2016 – Chapter 1-3: Introduction

Computer System Validation – The Regulated Software Life Cycle

21 CFR Part 820 Subpart I – Nonconforming Products

Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5