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Fundamentals of ISO 13485
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Fundamentals of ISO 13485

19 May 2026 | Short Online Course

Original price was: £350.Current price is: £280.

1-Day Live Online training | Master the essentials of ISO 13485 and learn how to implement a compliant, effective QMS for medical devices.

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Enrol before 1 May to save 20% (May Course)

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

ISO 13485:2016 is the internationally recognised quality management system (QMS) standard for medical device organisations. It underpins regulatory compliance in Europe, the US, and many global markets, forming the backbone of conformity assessments and regulatory audits.

 

This course provides a practical introduction to ISO 13485, exploring the fundamental requirements, the responsibilities of management, and how to implement and maintain an effective QMS. You will also learn how ISO 13485 interacts with product development, validation, and post-market processes.

 

Learn more about how we deliver live online training.

Download the Agenda

 

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

 

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Key Learning Objectives

 

  • Understand the purpose and structure of ISO 13485:2016
  • Identify the essential documentation and records required for compliance
  • Recognise the roles and responsibilities of management under the standard
  • Apply ISO 13485 principles to product development, manufacturing, and servicing processes
  • Understand monitoring, measurement, and continuous improvement expectations

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer through interactive and engaging sessions
  • Unlimited access to session recordings for 2 weeks after the course (live format)
  • One month of unlimited access to recordings and slides (on-demand format only)
  • Validated certificate of attendance, available to download or share on LinkedIn

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

19 May 2026

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

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

 

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.

 

This course is designed for professionals working in:

  • Regulatory Affairs (Medicinal & Device)
  • CMC and Pharmaceutical Development
  • Combination Product Development Teams
  • Quality Assurance and Compliance
  • Project Managers involved in EU submissions

On-Demand Access

Can’t wait for the next course date?

Get instant access to the training materials by selecting ‘On-Demand’ from the drop-down menu above. Start learning at your convenience. You’ll also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.

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Fundamentals of ISO 13485

19 May 2026 | Short Online Course

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