Medical Device Quality Management (ISO 13485) (QP-022) Training Course

Medical Device Quality Management (ISO 13485)

Medical device manufacturers must maintain quality management systems that meet ISO 13485 and regulatory requirements such as the EU Medical Device Regulation. Compliance…

5 daysClassroom or online

14Upcoming dates

7Cities

£2,750Fees from

Course overview

Why Attend

Medical device manufacturers must maintain quality management systems that meet ISO 13485 and regulatory requirements such as the EU Medical Device Regulation. Compliance is essential for market access and patient safety.

This LLMI course explains ISO 13485 requirements, risk management links, design and development controls, purchasing and supplier controls, production and process validation, complaint handling and vigilance, CAPA and regulatory interfaces. Participants assess gaps in a case quality system.

The course suits quality and regulatory professionals in the medical device sector.

Course Objectives

Explain ISO 13485 structure and requirements

Apply design and development controls

Manage suppliers and purchasing

Validate production processes

Handle complaints, vigilance and CAPA

Prepare for audits and regulatory inspections

Target Audience

Medical device quality professionals

Regulatory affairs staff

Design engineers

Production managers

Auditors

Suppliers to the medical device industry

Course Methodology

Standard walkthroughs

Case studies

Gap assessment exercise

Group discussions

Documentation reviews

Course outline

1Day 1: ISO 13485 Overview

Medical device regulation context
Structure of ISO 13485
Differences from ISO 9001
Documentation
Management responsibility
Exercise: Gap assessment start

2Day 2: Design and Risk

Design and development controls
Design reviews and verification
Risk management links
Usability
Design transfer
Workshop: Design control review

3Day 3: Suppliers and Production

Supplier controls
Purchasing
Process validation
Sterilisation and cleanliness
Traceability
Exercise: Process validation plan

4Day 4: Post-Market Processes

Complaint handling
Vigilance reporting
CAPA
Recalls
Post-market surveillance
Case study: Device complaint

5Day 5: Audits and Improvement

Internal audits
Notified body audits
Management review
Continuous improvement
Regulatory updates
Capstone: Quality system gap report

Frequently asked questions

How long is the Medical Device Quality Management (ISO 13485) course?

The course runs over 5 days of classroom training, usually Monday to Friday.

When is the next Medical Device Quality Management (ISO 13485) course?

The next public date is 16 - 20 Nov 2026 in Vienna. There are 14 upcoming dates in total.

Where is this course held?

Upcoming sessions run in Vienna, Barcelona, Rome, Munich, Amsterdam, London, Istanbul.

Can I take Medical Device Quality Management (ISO 13485) online?

Yes. Every date can also be joined live online in a virtual classroom with the trainer, for £1,280 per participant. Choose "Live online" in the dates table when you register.

How much does the course cost?

Fees start from £2,750 per delegate, depending on the city. Fees include tuition and course materials.

Do participants receive a certificate?

Yes. Delegates who complete the course receive a London Leadership Management Innovation certificate of completion.

Can this course be delivered in-house for our team?

Yes. LLMI can tailor and deliver this course privately for your organisation at your premises or in one of our training cities.

Course information last updated 14 November 2026.

Medical Device Quality Management (ISO 13485)

Course overview

Course outline

Dates and fees

Frequently asked questions

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