- Apply the principles of our successful Clinical Evaluation process to your CERs
- Build each section by following simple instructions
- Check your progress and phrasing using detailed examples
- Implement targeted clinical evidence identification, appraisal & analysis
- Streamline decision making and confidently select information for inclusion
- Become an accomplished and confident CER writer
- Also available in our bundle offers
Clinical Evaluation Report Template
Produce Clinical Evaluation Reports for any class of medical device using a proven start-to-finish methodology
Also included in our discount bundle offers
- Clinical Evaluation Premium / £1390 £1095
Step-by-step guidance for complete confidence
- 64-page PDF document
- Apply the principles of our successful Clinical Evaluation process to your CERs
- Build each section by following simple instructions
- Check your progress and phrasing using detailed examples
- Implement targeted clinical evidence identification, appraisal & analysis
- Streamline decision making and confidently select information for inclusion
- Become an accomplished and confident CER writer
In more detail
Apply a successful Clinical Evaluation process across your entire medical device portfolio.
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This template is designed for QA/RA professionals with some technical writing experience who wish to produce EU MDR-compliant CERs in-house without the need for consulting support. It is also suitable for company founders and members of early stage start-ups who have undergone our CER Writing Training Course.
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Over 60 pages of unparalleled guidance, detailed examples, writing and style guides, providing full coverage of EU MDR CER requirements. It is in a format that has consistently gained Notified Body approval.
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Try it for yourself by working with the free CER sample.
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Please see the CER comparison chart.
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No - following purchase, it is yours to keep without any additional payments.
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You will have access to the CER Template under a Single User Licence. If you require access for multiple team members, please contact us about our Multi User Licences.
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The template opens with any PDF application and requires no activation or access codes.
Try a free sample
Download a free sample of our CER Template to see how it works.
- Attain complete autonomy through a proven 14 section CER framework.
- Employ the rules to identify, appraise and analyse clinical evidence for developing and using search protocols.
- Build each section by following instructions and answering questions.
- Use the specimen text to gain insight on wording, phrasing and emphasis.
- Accelerate the production of high-quality Clinical Evaluation Reports and stay ahead of regulatory deadlines.
Our Clients say
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A comprehensive, detailed and highly professional service.
Kris Regulatory Manager
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Please thank all of your team for their brilliant efforts. Your standard of service, response time, and rigour were outstanding and I would strongly recommend you to any other potential client.
Andrew Quality Advisor
Comparison to free CER templates
Using a free Clinical Evaluation Report template or relying on MedDev guidelines may be tempting but often fails to meet MDR requirements.
* Free |
Mantra Systems CER Template |
|
|---|---|---|
CER structure outlineOverall guidance on structure |
Yes | Yes |
Literature review processGuidance on identifying, appraising and analysing clinical data |
Yes | Yes |
Comprehensive & completeCovers all MDR CER requirements |
No | Yes |
Line-by-line guidanceStart-to-finish guide to every section of the CER |
No | Yes |
Clear instructionsStep-by-step instructions for uncomplicated use |
No | Yes |
Easy to useSimple language and clear guidance |
No | Yes |
Illustrative examplesIncluded in each section to show correct language style and phrasing |
No | Yes |
Transposable textBlocks of text that can be used directly in the CER |
No | Yes |
Updated for EU MDRReflects the latest regulatory requirements |
No | Yes |
Download today
You can download and use your document template immediately after purchase.
Clinical Evaluation Report 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
Bundle offers
We also offer reduced price bundles of related training courses and templates.
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Clinical Evaluation Premium
- Clinical Evaluation Report Template
- Clinical Evaluation Plan Template
- MDR CER Writing Training Course
Prices shown exclude UK/EU VAT
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After payment you will get access to our Resources platform where all your purchases are stored.
Invoices can be found in your Settings > Billing section.
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