Clinical Evaluation Plan Template

Produce Clinical Evaluation Plans for any class of medical device using a proven structure designed by experts

Clinical Evaluation Plan Template

Single one-off payment £595

Buy now

Also included in our discount bundle offers

  1. Clinical Evaluation Premium / Full price £1390 Discounted bundle price £1095
  1. Technical Document Templates

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.

  1. 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.

  2. 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.

  3. Try it for yourself by working with the free CEP sample.

  4. Please see the CEP comparison chart.

  5. No - following purchase, it is yours to keep without any additional payments.

  6. 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.

  7. 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.

Download sample

  1. Attain complete autonomy through a proven 11 section CEP framework.
  2. Employ the rules to develop objectives and structures for search protocols.
  3. Build each section by following instructions and answering questions.
  4. Use the specimen text to gain insight on wording, phrasing and emphasis.
  5. Accelerate the production of high-quality Clinical Evaluation Plans and stay ahead of regulatory deadlines.

Clinical Evaluation Report template PDF sample Free sample

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.

    PT

    Chief Product Officer SaMD Company, Europe

  • A comprehensive, detailed and highly professional service.

    BG

    Regulatory 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.

* Includes the most searched for free options
Feature

* Free templates & MedDev 2.7/1 rev 4 guideline

Mantra Systems CEP Template

CEP structure outline

Overall guidance on structure

 Yes Yes

Literature review process

Guidance on developing a clinical evidence identification, appraisal and analysis plan

 Yes Yes

Comprehensive & complete

Covers all MDR CEP requirements

 No Yes

Line-by-line guidance

Start-to-finish guide to every section of the CEP

 No Yes

Clear instructions

Step-by-step instructions for uncomplicated use

 No Yes

Easy to use

Simple language and clear guidance

 No Yes

Illustrative examples

Included in each section to show correct language style and phrasing

 No Yes

Transposable text

Blocks of text that can be used directly in the CEP

 No Yes

Updated for EU MDR

Reflects the latest regulatory requirements

 No Yes

Download today

You can download and use your document template 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

  • 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 in our bundle offers

Single one-off payment £595

Buy now

Bundle offers

We also offer reduced price bundles of related training courses and templates.

  1. Clinical Evaluation Premium

    Full price, bought separately £1390

    Discounted bundle price £1095

    Buy now

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