MDR Academy

We'll give you the tools, templates & training to build your complete MDR technical file in-house

Matthew Stinson, Sales & Marketing Manager

See how our MDR Academy works Start your FREE TRIAL Or request a demonstration

A revolution in medical device regulatory support

Our Academy will accelerate your EU MDR transition and save you money.

  1. Document Management

    Document Management

    Powerful document management platform integrates your Risk Management, QMS & PMS files

  2. Risk Management

    Risk Management

    The complete medical device Risk Management program

  3. Quality Management

    Quality Management

    Become ISO 13485:2016 compliant through dedicated training, documents & resources

  4. Post-Market Surveillance

    Post-Market Surveillance

    All you need to produce MDR-compliant PMS systems for your entire device portfolio

  5. Templates Library

    Templates Library

    Extensive document template library within ISO 13485-compliant Document Management System

  6. CER Accelerator

    CER Accelerator

    Automated CER frameworks, document templates & section-by-section writing guide

Get started TODAY

Our Clients say

Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.


Chief Executive Officer Software Company, UK

What's included

For a low monthly subscription cost, you will get ongoing access to our suite of tools, templates & training videos, allowing you to build your complete MDR technical file at a fraction of the cost of outsourcing.

Start your FREE TRIAL Or request a demonstration

* Each additional seat at £50 per month. You can cancel your subscription at any time.
Feature Monthly subscription / Single seat * £895 (£1,074 inc. VAT)
Document Management System
Manages your Risk Management, Quality Management & Post-Market Surveillance files Yes - included
Flexible & customisable Yes - included
Compliant to all relevant standards Yes - included
Risk Management
Comprehensive training course Yes - included
Document templates Yes - included
Quality Management
ISO 13485:2016-based system Yes - included
SOP, Process & Document templates Yes - included
Comprehensive training course Coming soon
Post-Market Surveillance
Complete set of MDR Annex II & III technical document templates Yes - included
Comprehensive training course Coming soon
Templates Library
Full set of MDR Annex II & III templates Yes - included
Peer reviewed documents Yes - included

How it works

Our MDR Academy is designed to empower you and your team to build crucial regulatory systems and processes in-house, saving you time and money.

  1. Start learning immediately through detailed videos, seminars and downloads
  2. Build systems for your devices in lock-step with training course progress using document templates and resources
  3. Verify compliance through direct support, Q&A sessions and community engagement
  4. Access powerful document management software for version control, archiving, training and regulatory audit
  5. All this and more for a single monthly fee with no up-front charges

Get started TODAY

Get started today

To start your FREE 1-week trial or to request a demonstration, please complete the following form.

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Alternatively, please contact us if you would like to talk with our Academy team in more detail.

Call Monday-Friday 8am-8pm GMT

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