Medical Device Regulatory Resources
Our range of resources contain exclusive documents & guidance on all aspects of MDR compliance
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EU MDR Compliance Guide
- Post-Market Surveillance
- Risk Management
- Quality Management Systems
- Clinical Evaluation
- ... and 18 other topics
Our unique EU MDR Compliance Guide covers 22 topics relating to the new Medical Device Regulation (EU) 2017/745. It's free to use and combined with our online resources it will help direct your regulatory strategy.
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Articles & News
- PMCF strategies
- EU MDR Compliance guidance
- Clinical Evaluation best practice
- Future of the MDR
- ... and other subjects
Read our analysis on medical device regulatory requirements inlcuding our observations on developments in the industry.
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EU MDR Downloads
- MDReady Starter Guide
- Mastering the MDR White Paper
- PMS in the MDR White Paper
- CER Template & Gap Analyser
- ... and more
Our EU MDR Downloads include exclusive White Papers, Templates, Tools & Guides which will help you understand important areas of the medical device regulatory environment.
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PMCF Checker
- Answer 10 quick questions
- Get clarity about your PMCF obligations
- Takes just a few minutes
Our PMCF Checker is a quick test to see if your medical device needs a PMCF system for regulatory compliance.
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Video Library
- What is MDR Compliance?
- MDR stratgey guidance
- What is Post-Market Surveillance
- ... and other videos
An archive of our publicly available videos discussing the EU MDR and our services.
MDR Academy
- Document Management
- Risk Management
- Quality Management
- Post-Market Surveillance
- Templates Library
- CER Accelerator
Our MDR Academy integrates education, training, support, templates and full document management into a platform which will empower your team to implement critical components of your MDR strategy without the need for outsourcing.
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Get our MDReady Starter Guide A complete starter guide to get ready for the EU MDR
Free download - MDReady Starter Guide Guide See all our downloads