Design Review Record Template – Free

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This is a downloadable Word-file template for a design review record. It will facilitate the proper documentation of a design review meeting. The template addresses requirements from clause 7.3.5 in ISO 13485:2016 and §820.30 (e) in 21 CFR 820.

Description

Why it is useful

A design review record is required to record the results of design reviews. The purpose of design review is to evaluate the adequacy of the product requirements and the design’s ability to meet the requirements.

How to use it

  1. Design reviews must be planned. This may be done in the design and development planning or in the records from previous design review meetings.
  2. Design review can be held by the developers of each subsystem of a medical. Often there will be multiple design reviews per subsystem. It may be appropriate to have multiple reviews as the design progresses. Remember, the goal is to detect issues as early as possible!
  3. The project-level design reviews should be organized and led by the project manager.
  4. Design users, resident experts, peer designers, and cross-functional team members should participate in these design review reports. For design reviews for products that are to be sold to US, one or several persons that are not directly responsible for the design stage being reviewed, shall be present on the meeting. This person(s) are often referred to as independent person. Ideally, this person shall be as competent in the field as the people doing the design work.

Take a look at our online course: Introduction to Design Control for Medical Devices. Learn about the overall design and development process and how design control requirements should be implemented. Created by industry experts. Certification on successful completion of course.

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