MDR Academy
We'll give you the tools, templates & training to build your complete MDR technical file in-house
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.
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Document Management
Powerful document management platform integrates your Risk Management, QMS & PMS files
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Risk Management
The complete medical device Risk Management program
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Quality Management
Become ISO 13485:2016 compliant through dedicated training, documents & resources
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Post-Market Surveillance
All you need to produce MDR-compliant PMS systems for your entire device portfolio
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Templates Library
Extensive document template library within ISO 13485-compliant Document Management System
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CER Accelerator
Automated CER frameworks, document templates & section-by-section writing guide
Our Clients say
Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.
KWChief 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.
| 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.
- Start learning immediately through detailed videos, seminars and downloads
- Build systems for your devices in lock-step with training course progress using document templates and resources
- Verify compliance through direct support, Q&A sessions and community engagement
- Access powerful document management software for version control, archiving, training and regulatory audit
- All this and more for a single monthly fee with no up-front charges
Get started today
To start your FREE 1-week trial or to request a demonstration, please complete the following form.
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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