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Who should perform the clinical evaluation?

Clinical evaluation is a responsibility of the manufacturer and the clinical evaluation report is an element of the technical documentation of a medical device. deemed appropriate, an adequate justification has to be given.

Who can write a clinical evaluation report?

A CER can be written by your companys in-house staff, an external consultant, a contract research organization, or a freelance technical writer.

What is a clinical evaluation report?

A Clinical Evaluation Report (CER) is an important technical document that summarises the Clinical Evaluation of a medical device. An effective Clinical Evaluation Report describes a structured appraisal and analysis of all available clinical evidence to assess the safety and performance of a medical device.

How do you write a cep?

The CEP should include the following information: An overview of the device(s), including a device description, intended purpose indications/contraindications, and operating procedures. Usability of the device for the intended users and the suitability of the information materials.

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.

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What is a clinical evaluation specialist?

A clinical evaluator must examine the information from a variety of sources, including medical publications, clinical trials, clinical performance, competitor product performance, and post-market surveillance.

What is included in a clinical evaluation report?

A list of possible elements to include in the CER is as follows: General information, i.e., device and manufacturer name. Concise physical and technical device description and intended purpose. Outline of therapeutic or diagnostic claims with supporting data.

What are the requirements for an evaluation report?

What should be included in an evaluation report? There are six main sections in most evaluation reports: the introduction, background information, criteria, evaluation, conclusions, and recommendations. The order in which these are presented in the report may vary depending on the purpose and audience of the report.

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