Quickly evaluate your regulatory strategy against EU MDR requirements for all your medical devices
Technical Document Templates
- Choose the resources you need
- Eliminate doubt in your systems
- CERs, CEPs, Annex II & more
- Step-by-step guidance from experts
- Direct, immediate & future-proof
Choose your resources
Build your technical file through proven frameworks enhanced by detailed guidance from our specialists.
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Gap Analysis Tool Evaluation spreadsheet
Single one-off payment £95
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Free CER Template 22-page PDF document
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 64-page PDF document
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 45-page PDF document
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 24 fill-in 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 21 fill-in templates
The comprehensive solution to producing EU MDR Annex II technical documents for your medical devices
Single one-off payment £295
Online Video Training Courses
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A range of professional online video training courses suitable for any existing level of regulatory knowledge.