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Compiling and Managing Technical Documentation for Medical Devices
22 & 23 June 2026 | 2-Day Live Online Course
Original price was: £595.£476Current price is: £476.
Learn how to compile, structure, and maintain compliant technical documentation for UK and EU MDR
Learn more about the course by toggling through the tabs below.
Course Overview
Technical documentation (technical files) is the foundation of regulatory compliance for medical devices, providing evidence that a device meets all applicable safety and performance requirements under both the EU MDR (2017/745) and UK MDR (2002, as amended).
This course provides a comprehensive overview of how to compile, structure, and maintain technical documentation in line with MDR expectations and Notified/Approved Body requirements. Participants will gain insight into the required documentation, conformity assessment routes, document control best practices, and how to prepare for regulatory audits and reviews.
Interactive examples and group exercises will help attendees understand how to apply the regulations to real-world documentation challenges and ensure ongoing compliance across the device lifecycle.
Key Learning Objectives
- Understand the purpose, structure, and content of technical documentation under UK and EU MDR.
- Identify differences and similarities between UK MDR 2002 (as amended) and EU MDR 2017/745.
- Compile compliant technical files, linking key evidence and traceability elements.
- Apply best practices for document control, versioning, and change management.
- Prepare technical documentation for review by Notified or Approved Bodies.
- Recognise common non-conformities and how to address regulatory feedback.
Who Should Attend?
This course is suitable for professionals across the medical device and IVD sectors, including:
- Regulatory Affairs and Quality Assurance professionals
- Design & Development Engineers
- Clinical & Risk Management Specialists
- Manufacturing and Operations Managers
- Post-Market Surveillance & Vigilance personnel
It is particularly valuable for those creating or maintaining technical files or preparing for Notified/Approved Body audits.
Course Outline
Course Information
- The course begins at the time stated below
- The course is broken up into modules outlined below
- There will be breaks between modules
22 & 23 June 2026
1-Day Live Online Training
Register at the top of the page.
Session 1 | Day 1
210 mins | 1:00 PM UK
Introduction to the course and overview of technical documentation in the context of medical device regulatory compliance
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Introduction to Medical Device Regulations
- Overview of UK MDR 2002 (as amended) and EU MDR 2017/745
- Key definitions: medical device, intended purpose, classification
Technical Documentation: Purpose and Regulatory Context
- The role of technical documentation in demonstrating MDR compliance
- Why technical documentation is critical for conformity assessment and CE/UKCA marking
Structure of the Technical File
- Options for content layout based on GHTF STED and IMDRF templates
- Required sections: device description, design, manufacturing, risk management, clinical data, PMS, and labelling
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Document Control and Version Management
- Best practices for document control, versioning, and archiving
- Change management procedures
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Interactive Exercise
Participants review and assess a sample technical file checklist, identifying strengths and missing compliance elements.
Session 2 | Day 2
210 mins | 1:00 PM UK
Compiling, Maintaining, and Auditing Technical Documentation
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Compiling the Technical File
- Gathering and organising evidence
- Linking supporting documents and traceability
Addressing Key Regulatory Requirements
- Biocompatibility, sterilisation, and validation evidence
- Clinical data and post-market clinical follow-up
- Unique Device Identification (UDI) and Eudamed registration (EU)
- Labelling
Audit Readiness and Regulatory Feedback
- Preparing for audits and regulatory reviews
- Common findings and how to address them
Change Management and Ongoing Compliance
- Managing significant changes and updates
- Post-market surveillance and vigilance reporting
Interactive Group Exercise
Participants perform a gap analysis on example documentation to identify areas for improvement and create an action plan for compliance.
Q&A and Wrap-Up
Annette Callaghan is a quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
22 & 23 June 2026
7-Hour Course Delivered Over 2-Days
Register at the top of the page.
Course Times
For live online delivery, both sessions start at 1:00 PM (UK time) and finish at 4:00/4:30 PM (UK time).
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.
What is Included?
Certification
Download your official Educo Life Sciences Certificate of Attendance to showcase your achievement and professional development.
Access to Recordings for 2 Weeks
Enjoy unlimited access to all session recordings for up to two weeks after the final session — perfect for revision or catching up.
Learner Reference Guide
Attendees receive an overview packed with key concepts, examples, and references from your training to support you long after the course concludes.
On-Demand or Live Online
This course is delivered live or you can access on-demand materials immediately to begin learning straight away.
7 Hours of Learning
This course includes a total of 7 hours of learning.
Expert Trainer
Engage directly with leading trainers who bring real-world experience and insider knowledge to every session.
Additional Course Information
Free Online Module
Free Online Module
- Some of our courses include a free to attend module 1. Please check above to see if this applies to this course.
- If applicable, module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
- To register for module 1, please submit your details in the form located above.
- Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
Full Course Information and Pricing
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 either online or in a classroom. Please check which course format you have booked.
- For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
- 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.
On-Demand Information and Pricing
On-Demand Information
- Most courses are available on-demand. If you select this option you will be able to begin training instantly.
- You will gain access to a previous live online session, slides and learner reference guide.
- You will also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
- Depending on the course length you will have access to the on-demand materials for 1 to 3 months.
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