# What is the best requirements management software for medical device manufacturers?

I want to start a discussion with G2 experts in the Requirements Management software community on G2. I'm looking into what the best requirements management tool is for teams building medical devices, in the context of the software category on G2: Best Requirements Management Software.


Most requirements tools were built for software or aerospace and then stretched to fit medical. The device world has its own problem: every requirement has to survive an audit, link to a risk and a test, and hold up years later when a notified body asks how you got there.


Here's a quick list of my top 5 picks with what they're best known for, and a question for each about how they hold up under design controls.


1. Matrix Req: The one built specifically for medical device teams rather than adapted to them. Requirements, risks, tests and design controls sit in one system, and the traceability matrix and technical file come out of the tool instead of being assembled by hand. It says 500+ life science and device companies use it, with 91% reporting more confidence going into an audit. It's the only product I found listed on G2 in both Requirements Management and Medical QMS. 

Their overview is here: <a class="a a--md" elv="true" href="https://www.matrixone.health/products/matrix-req">https://www.matrixone.health/products/matrix-req</a>


2. Jama Connect: The best known name in the category and strong on live traceability and review workflows across large programmes. Widely used in safety critical industries beyond medical.


3. Polarion: Siemens' ALM platform, strongest when requirements have to sit alongside a wider PLM and engineering toolchain.


4. Codebeamer: PTC's option, known for flexibility and for handling complex variant and configuration management in regulated development.


IBM Engineering Requirements Management DOORS Next: The long standing enterprise standard. Deep capability, deep learning curve, still common in bigger organisations.

A few things I'd genuinely like to hear on:

Which matters more in practice, a tool that covers requirements, risk and test in one system, or a specialist requirements tool wired into everything else?

For anyone who has been through an ISO 13485 audit or an FDA submission with one of these, did the traceability actually hold up, or did someone still end up rebuilding the matrix in Excel the week before?

And for those who have implemented one, which delivered the best return and why?

##### Post Metadata
- Posted at: 3 months ago
- Author title: Marketing Asst.
- Net upvotes: 1


## Comments
### Comment 1

For multidisciplinary devices, Matrix Req has helped me keep hardware requirements, software requirements, risks, and verification evidence connected in one project, so I can see how the full system fits together. We were struggling with traceability across disciplines, and having one connected requirements system makes it easier to spot missing links before they turn into issues during V&amp;V or an audit. It still takes thoughtful project architecture on complex programs, but the tool gives enough flexibility to build that structure.

##### Comment Metadata
- Posted at: 16 days ago
- Author title: Systems Engineering




## Related Product
[Matrix Req](https://www.g2.com/products/matrix-req/reviews)

## Related Category
[Requirements Management](https://www.g2.com/categories/requirements-management)

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