Design reviews are one of the key processes during the design and development process of medical devices.
They are checkpoints to see whether the design process is still on track and moving forward as it’s supposed to. This makes total sense from an organizational point of view but as well, in regulated environments such as medical devices, it is not surprising that these kind of intermediate checks are required.
In general, the requirements for design reviews are:
- At appropriate stages
- Performed by specialists and independent reviewers
So some of the basic, but critical questions to be asked when it comes to design reviews are:
- How often should we do a design review?
- When to perform the design reviews?
One key thing not to forget is that design reviews should be useful. Don’t organize them for the sake of your medical device documentation. That would be very sad.
You want to do them because they make sense, because they help your team to move forward.
In a classical V-model or waterfall model, it is straightforward to define when are the critical points in time to perform design reviews.
How can you fit them into an agile development environment?
How do you fit something that needs to be planned into an environment that can change all the time?
In an agile environment, you go through many iterations during your development process. So many that it's practically impossible to organize a big review every time.
What is the best approach then? To organize only one big review at the very end?
One of the basic principles of agile development is to break up the big chunks into smaller parts, and this can be done for design reviews as well.
- Don’t go for the big ones every time, but do as many small ones as you can. Who is actually required to do each review?
- Make sure that the team are aware of ongoing changes.
- Organize only a few big design reviews at critical time points in the process.
“All very nice in theory, but what about the documentation part?!", I can hear you say.
A software tool that allows your team to collaborate on design input and design output can make a big difference in how easy it is to document design reviews efficiently.
What is our solution?
Matrix Requirements software is aimed at providing you the possibility to collaborate on the creation of your medical device in an agile way.
Our solutions facilitate the collaboration within the team and create an environment to work together in the most efficient way.
That’s why we have introduced the Agile Review Module.
We give you the possibility to easily create Review items where you can select the items to be reviewed, the reviewers, their comments, etc. All online, all in the same platform where you document your design.
This allows easy documentation as the content of your documents can be extracted from your database, together with all related information for example who performed the review and when. This way you'll always have the most updated information!
How does it work?