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There are four discrete stages to perform a clinical evaluation of a medical device. Stage 0: Scope and plan. ... Stage 1: Identification of pertinent data. ... Stage 2: Appraisal of pertinent data. ... Stage 3: Analysis of the clinical data. ... Stage 4: Finalize the report.

The overall aim of a clinical evaluation is to assess and analyze clinical data regarding the medical device to provide evidence for the product's clinical safety and performance.

A document called a Clinical Evaluation Report (CER) is where the results of the Clinical Evaluation Plan (CEP) process is defined which leads to the analysis and conclusions which is then recorded and documented in the report.

Clinical Evaluation Plan (CEP) - Requirements Intended purpose and medical indications. Intended target population with indications and contraindications. Equivalence information (if claimed) State-of-the-art in the corresponding medical field.

Writing a Clinical Evaluation Report: 5 Quick Tips Define a CER protocol and strategy. Demonstrate equivalence. Evaluate literature review data. Determine requirement for clinical investigation. Monitor post-market activities.

The clinical Evaluation Plan is a road map for conducting the clinical evaluation process. It includes the scope, methodological, and systematic approach on how to proceed and reach a conclusion on the clinical evaluation, to document it in a CER.

Writing a Clinical Evaluation Report: 5 Quick Tips Define a CER protocol and strategy. Demonstrate equivalence. Evaluate literature review data. Determine requirement for clinical investigation. Monitor post-market activities.

How to prepare a Clinical Evaluation Report for medical devices General information: device and manufacturer name. Concise physical and technical device description and intended application. Outline of intended therapeutic or diagnostic claims. Clinical evaluation and data types. Summary of clinical data and review.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232