Design Review

This blog talks about design review, another important part of design control. Design Project Plan shall schedule when to have the design reviews. Design review is an important milestone in the design process of medical device.

Should there be a minor upgrade to an existing device, may be a single review is warranted.

For a whole project or a substantial changes to an existing device, several design reviews are warranted. Design review must be done logically, in detail and be recorded.

The first review portion should start early in the project, to evaluate and finalize design input requirements, to review risk management, and to review early conceptual design.

The second portion shall review design verification phase and the review purpose is to ensure design input meets design output requirements and perhaps to finish continuing risk management and to review the design output.

The last portion of the review should deal with the completion of production trial runs and design validation. The purpose of this portion of design review is to ensure the device meets user and production requirements. An evaluation of the final risk management report is also be reviewed.Of course, the above sequence of design review is just a suggestion.

The project manager can decide what portion of design review can be started based on priority or need. For example, for more complex design, the project manager can schedule additional design reviews to ensure the design review was done in focus, thorough and in compliance.

How about Label and Document Review? A review of the label and document should also be part of the design review. A review of the labeling include manuals, instruction for use, chart, package insert and labels and they should all be reviewed methodologically and ensure to be compliant to all pertinent guideline like 21 CFR 820 and ISO 13485, for example.

The portion of this review may be part of the Final Design Review. This can be a separate review because it may involve a wider range of participants like regulatory affairs, finance and marketing.

After all the documents are reviewed, they will be released in the Device Master Record.Project manager should have a Design Review Checklist (DRC) to identify the project and the phase being reviewed, the date, time, place, the participants, the review topic, any documents reviewed and outstanding action items. DRC should be distributed prior to the meeting to ensure participants prepare for the review.

Depending on the review topic, participants should involve project manager, process engineering, quality assurance, regulatory affairs, marketing and consultants etc.

Results of design reviews are recorded in minutes of the meetings prepared. Examples of the record includes:

·       Copy of the agenda for the meeting.

·       Place, date, time and list of participants with their name and signatures.

·       Disposition of outstanding action items and the actions necessary to resolve them. Detail of disposition is warranted.

·       Notes, results and conclusions for each reviewed item,

·       Requested corrections and changes, and actions necessary to implement them,

·       Approvals and consents with signatures and date.

·       Risk Analysis Report.

·       Engineering Drawings and Specifications.

·       Clinical Trial Report.

·       Instruction For Use.

Finally, all records pertain to design reviews are placed into the Design History File both hardcopy and softcopy.

Reference	Criteria
21 CFR 820.30(e)	Does the company establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development?
21 CFR 820.30(e)	Do the procedures ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed?
21 CFR 820.30(e)	Are the results of a design review, including identification of the design, the date, and the individual(s) performing the review, documented in the design history file (DHF)?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.