- 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 to purchase in our package offers
EnableCE Build 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 package offers
- Clinical Evaluation Templates / £1390 £1095
- Clinical Evaluation Plus / £1490 £1195
- Clinical Evaluation Premium / £2085 £1395
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 Customers say
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A comprehensive, detailed and highly professional service.
BGRegulatory Manager Manufacturer, UK
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We were in the process of creating our first Clinical Evaluation Report and needed some guidance and examples. Your CER Template gave us a structure for our report and made decision making easier on what we should include. It certainly sped up our writing process and we would recommend it to others.
PTChief Product Officer SaMD Company, Europe
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 guidance document 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
Package offers
We also offer reduced price packages of related training courses and templates.
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Clinical Evaluation Templates
- Clinical Evaluation Report Template
- Clinical Evaluation Plan Template
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Clinical Evaluation Plus
- Clinical Evaluation Report Template
- CER Writing Training Course
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Clinical Evaluation Premium
- Clinical Evaluation Report Template
- Clinical Evaluation Plan Template
- CER Writing Training Course
Prices shown exclude UK/EU VAT
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For all purchases, you will receive a receipt by email confirming payment.
Templates & tools:
You will receive an email containing a link to download your files.Training courses:
You will go through the account set up process to access the training course platform.Training course + template package:
You will go through the account set up process to access the training course platform. Within one working day you will receive an email to download your template(s).
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