- Apply the principles of our successful Clinical Evaluation process to your CEPs
- Build each section by following simple instructions
- Check your progress and phrasing using detailed examples
- Design a strategy for targeted clinical evidence identification, appraisal & analysis
- Develop a robust & detailed CEP that will form the bedrock of a successful Clinical Evaluation process
- Also available to purchase in our package offers
EnableCE Build Clinical Evaluation Plan Template
Produce Clinical Evaluation Plans for any class of medical device using a proven structure designed by experts
Also included in our discount package offers
- Clinical Evaluation Templates / £1390 £1095
- Clinical Evaluation Premium / £2085 £1395
Step-by-step guidance for complete confidence
- 45-page PDF document
- Apply the principles of our successful Clinical Evaluation process to your CEPs
- Build each section by following simple instructions
- Check your progress and phrasing using detailed examples
- Design a strategy for targeted clinical evidence identification, appraisal & analysis
- Develop a robust & detailed CEP that will form the bedrock of a successful Clinical Evaluation process
In more detail
Plan successful Clinical Evaluations across your entire medical device portfolio.
-
This template is designed for QA/RA professionals with some technical writing experience who wish to produce EU MDR-compliant CEPs 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.
-
Over 40 pages of expert guidance peer-reviewed by medical professionals. It provides full coverage of EU MDR CEP requirements and is in a format that has consistently gained Notified Body approval.
-
Try it for yourself by working with the free CEP sample.
-
Please see the CEP comparison chart.
-
No - following purchase, it is yours to keep without any additional payments.
-
You will have access to the CEP Template under a Single User Licence. If you require access for multiple team members, please contact us about our Multi User Licences.
-
The template opens with any PDF application and requires no activation or access codes.
Try a free sample
Download a free sample of our CEP Template to see how it works.
- Attain complete autonomy through a proven 11 section CEP framework.
- Employ the rules to develop objectives and structures for 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 Plans and stay ahead of regulatory deadlines.
Our Customers say
-
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
-
A comprehensive, detailed and highly professional service.
BGRegulatory Manager Manufacturer, UK
Comparison to free CEP templates*
Using a free Clinical Evaluation Plan template or relying on MedDev guidelines may be tempting but often fails to meet MDR requirements.
* Free |
Mantra Systems CEP Template |
|
|---|---|---|
CEP structure outlineOverall guidance on structure |
Yes | Yes |
Literature review processGuidance on developing a clinical evidence identification, appraisal and analysis plan |
Yes | Yes |
Comprehensive & completeCovers all MDR CEP requirements |
No | Yes |
Line-by-line guidanceStart-to-finish guide to every section of the CEP |
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 CEP |
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 Plan 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
Package offers
We also offer reduced price packages of related training courses and templates.
-
Clinical Evaluation Templates
- Clinical Evaluation Plan Template
- Clinical Evaluation Report Template
-
Clinical Evaluation Premium
- Clinical Evaluation Plan Template
- Clinical Evaluation Report Template
- CER Writing Training Course
Prices shown exclude UK/EU VAT
-
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).
You may also be interested in…
-
Learn Understanding the EU MDR Training Course
Gain clarity & context on overall EU MDR requirements for your entire regulatory strategy
-
Learn CER Writing Training Course
Uncover the secrets of our successful Clinical Evaluation process and become a confident writer of CERs
-
Build CER Template Guidance Document
Produce Clinical Evaluation Reports for any class of medical device using a proven start-to-finish methodology