Home
Forms Library
Clinical evaluation plan template

Clinical evaluation plan template 2025

clinical evaluation plan template Preview on Page 1

Show details

4.9 out of 5

24 votes

The document is a 26-page Clinical Evaluation Plan Template designed for medical devices, following the guidelines of MEDDEV 2.7/1. It outlines the necessary procedures for evaluating the clinical performance and safety of a medical device, including its intended purpose, methods for clinical evaluation, and documentation requirements. The plan emphasizes the importance of ongoing evaluation throughout the device's lifecycle and compliance with relevant regulations and standards.

Here's how it works

01. Edit your clinical evaluation plan template online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send clinical evaluation plan example via email, link, or fax. You can also download it, export it or print it out.

The best way to modify Clinical evaluation plan template in PDF format online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Working on documents with our comprehensive and intuitive PDF editor is straightforward. Adhere to the instructions below to complete Clinical evaluation plan template online quickly and easily:

Sign in to your account. Log in with your credentials or create a free account to try the product prior to choosing the subscription.
Upload a document. Drag and drop the file from your device or import it from other services, like Google Drive, OneDrive, Dropbox, or an external link.
Edit Clinical evaluation plan template. Effortlessly add and underline text, insert images, checkmarks, and symbols, drop new fillable fields, and rearrange or remove pages from your paperwork.
Get the Clinical evaluation plan template completed. Download your adjusted document, export it to the cloud, print it from the editor, or share it with other people via a Shareable link or as an email attachment.

Take advantage of DocHub, one of the most easy-to-use editors to rapidly manage your documentation online!

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What are the elements of an evaluation plan?

Elements of an Evaluation Plan Purpose of the Evaluation. Evaluation Questions. Evaluation Criteria. Timetable and Work Plan. Collecting Data for an Evaluation. Data Collection Methods To Answer Evaluation Questions. Data Collection Tools and Activities. Data Analysis.

How do you write a clinical evaluation?

Structure of a Clinical Evaluation Report Executive summary. Scope. Device description. Clinical background/state of the art. Preclinical/nonclinical data. Appraisal of clinical data (including the literature report) Analysis of clinical data.

What is an evaluation plan template?

The Evaluation Plan Template identifies the key components of an evaluation plan for a particular program or activity. It provides guidance about the information typically included in each section of a plan for evaluating efficiency, effectiveness and/or appropriateness of a program or activity.

How do you write an evaluation step by step?

How to Write an Evaluation Essay? Create an Outline of the Essay. After choosing the topic and researching it, make an outline for your essay. Write a Strong Introduction. Add a Thesis Statement. Draft the Main Body of the Essay. Write a Good Conclusion. Edit, Revise, and Proofread.

What is a clinical evaluation plan?

The CEP is the first and the principal document to be prepared. It gives stepwise planning for the activities to be carried out. This plan helps to continuously guide and document a clinical evaluation. A clinical evaluation plan is a structured document that outlines how a medical device will be clinically evaluated.

clinical evaluation plan template mdr

Clinical evaluation plan template MDCG Clinical Evaluation Plan for medical devices Clinical Evaluation Plan MDR Clinical evaluation plan MDCG Clinical evaluation report Clinical evaluation report sample PDF Clinical development plan MDR Clinical evaluation example

Related forms

be ready to get more

Complete this form in 5 minutes or less

Get form

How do I write an evaluation plan?

The evaluation plan should include information about what the evaluation is trying to do (what is to be evaluated, the purposes of the evaluation and key evaluation questions) and how it will be done (what data will be collected, how and when, how data will be analyzed, and how and when results will be reported).

What is the difference between CEP and CER?

The CEP plans and describes the clinical evaluation strategy, while the CER presents the output of the clinical evaluation, i.e. the clinical data that demonstrate conformity with general safety and performance requirements when your device is used as intended.

Clinical evaluation plan template 2025

Here's how it works

The best way to modify Clinical evaluation plan template in PDF format online

Complete this form in 5 minutes or less

Got questions?

What are the elements of an evaluation plan?

How do you write a clinical evaluation?

What is an evaluation plan template?

How do you write an evaluation step by step?

What is a clinical evaluation plan?

Complete this form in 5 minutes or less

People also ask

How do I write an evaluation plan?

What is the difference between CEP and CER?

clinical evaluation plan pdf

Try more PDF tools