Evaluate your regulatory strategy against EU MDR requirements for all your medical devices
Technical Document Templates
Become self-reliant when writing your technical documents
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Gap Analysis Tool
Single one-off payment £95
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Free CER Template
Get an overview of a proven structure for MDR-compliant CERs for any class of medical device
FREE
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Full CER Template
Produce Clinical Evaluation Reports for any class of medical device using a proven start-to-finish methodology
Single one-off payment £795
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CEP Template
Produce Clinical Evaluation Plans for any class of medical device using a proven structure designed by experts
Single one-off payment £595
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Risk Management Templates
Build an adaptive & ISO 14971:2019-compliant Risk Management system for all your medical devices
Single one-off payment £295
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Annex II Templates
The comprehensive solution to producing EU MDR Annex II technical documents for your medical devices
Single one-off payment £295
Online Training Courses
- Introductory to advanced topics
- Step-by-step guidance from experts
- Choose the right content for you
- Stream videos online 24/7
- Gain certainty & peace of mind
A range of professional on-demand training courses suitable for any existing level of regulatory knowledge.