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Design review is a valuable chance to stop and evaluate the situation when you are developing a medical device. Are the design requirements adequate? Is the design likely to meet these requirements? And, are there any problems that are yet to be identified?
In this video, you will find out more about how to best conduct a design review and what pitfalls to watch out for. If you want to know even more about design review and design control, check out the full online Introduction to Design Control course.
Without a doubt! It is always better to fix an issue before the product has reached the market, rather than after. And design review should be an effective tool to find issues. But not only is it smart to do design reviews, it is also a regulatory requirement.
The term design review comes from the Quality System Regulation (QSR) and in the ISO 13485 this is referred to as design and development review.
A design review should always be planned in advance. Thus, you can’t have ad hoc design reviews unless you create a plan before you have them.
There are several ways to perform a design review, but the most common way is to have a meeting with 5-10 people where you go over the design, requirements, and potential problems. Depending on the information available, the meeting can take anywhere from one to several hours.
Only relevant and competent individuals should attend the design review meeting. Representatives of all functions related to the design stage being reviewed should be present at the meeting, along with any necessary specialists.
To satisfy requirements for selling a medical device to US, at least one person taking part in the design review meeting is required to not have any direct responsibility for the design stage. This person is often called an independent person. If you work for a small company, you might have to bring in an external consulting resource who is sufficiently independent.
Actually, there is no mention in the ISO 13485 or QSR of how many design reviews you have to perform on your medical device, only that you are required to perform them when appropriate.
As such, the minimum requirement would be to perform a design review once, but a more reasonable amount would be a handful. However, if you have a very advanced or complicated device, you may need even more design reviews.
It is required to maintain records of design review meetings. The simplest and typical way of doing so is to write minutes of meetings. They are records that should be kept according to your quality management system.
During a design review, you will likely find issues or even nonconformities that need to be addressed. You have to keep records of the necessary actions that you have identified.
The simplest way to do this is to add the actions as a task list in the minutes of the design review meeting. You can also record action items in a validated CAPA system or another similar database. The important thing is that you have a method to deal with the action items and maintain records of them.
A common mistake is that the project team forgets to follow up and properly close the open action items. Make sure to follow-up previous action items in every design review and even schedule separate follow-up meetings to make sure action items are closed in a timely manner.
Many organisations will also have a template for reviewing records, so if you have not performed a design review before, check if there is a template available.
On Medical Device HQ you can find a selection of templates, including a template for design review records.
Get instant access to our online Design Control for Medical Devices course right here. In 6 hours, you can learn more about how to develop new medical devices and maintain them in organisations where design control requirements apply. This course is taken by quality assurance, project management, design engineering or those involved in R&D and product development teams.
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.
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