Course Outline

Course Information

• The course begins at the time stated at the top of the page
• The course is broken up into modules outlined below
• There will be breaks between modules

19 May 2026

1-Day Live Online Training
Register at the top of the page.

Session 1

120 mins | 10:00 AM UK

Introduction to ISO 13485:2016

• Purpose, scope, and structure of the standard
• Relationship to regulatory requirements (MDR, IVDR, FDA QSR, MDSAP)
• Key principles of a quality management system for medical devices

Structure and Documentation of a QMS

• Required documentation and records under ISO 13485
• Best practices for document control and record keeping
• Integration of risk management principles

Management Responsibilities

• Leadership commitment and accountability
• Establishing roles, responsibilities, and infrastructure
• Internal communication processes and management review

Session 2

120 mins | 10:00 AM UK

QMS in Practice: Product Development & Validation

• Human resources and working environment requirements
• Product realisation: design, development, and medical device file content
• Process validation across the product lifecycle (design, manufacturing, servicing)
• Customer-related processes and supplier controls

Monitoring, Measurement, and Improvement

• Methods for monitoring QMS performance
• Gathering and analysing data for improvement
• Feedback loops and corrective/preventive actions

Wrap-Up and Q&A

• Linking ISO 13485 compliance to regulatory success
• Practical case examples and lessons learned
• Final Q&A session

Richard Young has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.

Richard has worked on many software related projects for clients helping them achieve regulatory compliance in the EU. In addition, he has delivered both online and classroom training courses on medical device software. He can provide multiple examples and case studies during training, drawing on his extensive industry experience.