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Anybody know of a good web-based requirements management tool? I am looking for tools that work well for medical products that are either electro-mechanical or software only.
< 1 min reading time
As originally asked by Rory A. Carrillo.
Don’t forget GxpManager. It has been created for life science industries and it has also a specific application for Medical Device
If you’re going to the Medical Devices Summit West 2013 – June 13/14 we will be there.[http://www.opalevents.org/p/72/|leo://plh/http%3A*3*3www%2Eopalevents%2Eorg*3p*372*3/0BzX?_t=tracking_disc]
All the Best,
Rory A. Carrillo
Just to be clear, I have used several different requirement management tools. ReqPro, DOORS, RM Trak and the like. They all have there pros and cons. After not only using several tools while leading product development of highly complex electro-mechanical and software systems, I’ve decided that a web-based tool provides advantages in terms of ease of setup (@Nuno mentioned this in his last comment). Since I am now doing consulting for a lot of early stage startups, this is easiest for them to get started. The other advantage is that a lot of my clients have developers that work remotely, and a web-based database won’t run as slow as a client trying to talk to some database on a server thousands of miles away (and if the developer needs to be on VPN in order to get access to all the database elements then this will likely slow down the process as well).
Ideally the RM tool will enable me customize the architecture however I see fit. I’ve done this several times and I agree with previous comments about there is not one solution that work perfectly out of the box. I have been able to develop an architecture that allows everything from design input requirements, to hazard and risk analysis, to design output elements and V&V protocols and reports to be properly captured, maintained and traced. I’m currently in the process of developing another architecture for a client but with an application that wasn’t designed for RM tracking whatsoever.
With all that said, I am always looking for new tools to help me develop this process as this is a very important piece of product development that not a lot of people understand, especially those in the start-up world. So finding a tool that is cheap, easy integrate, and easy to use is key for helping me “sell” this as a necessity.
Lastly, I have never had to do any validation on these tools and do not anticipate that I wil need to. These RM tools are advertised as simple development tools that the development team uses. Outputs of these systems are exported in a fashion that enable me to maintain everything within the DHF as if it were never used. These tools can be viewed similarly as Microsoft Word or Excel which help capture the requirements or whatever DHF elements it may be, but it no way is it creating the product or being used to make decisions on the performance, safety and/or efficacy of the product.
Again, thank you all for your feedback. I would appreciate feedback from those who have used a particular tool in the past and what their likes and dislikes have been using the product.
We’re testing the product with very large, with very stringent requirements for safety, traceability and formal checking. By enabling true cloud deployment the team can focus on their project and not be distracted by issues such as infrastructure, complex licensing etc. We are working on getting a handful projects off the ground to prove the tool (I didn’t claim it was market ready), but believe me: our lead customers are dying to minimize their dependency on legacy tools and are quite keen for us to get this product proven so they can use it themselves.
Having many years of industry use is a weakening criteria for selecting software tools (albeit a common one). This product is being put together by a team with 20+ years experience in developing very high integrity software (e.g. using formal methods) for all standardization requirements (medical devices, aerospace, space, railway), this is not just another startup.
For those with interested in knowing more, please do get in touch.
Some of my presentations give more details: [http://www.grahlmann.net/presentations.htm|leo://plh/http%3A*3*3www%2Egrahlmann%2Enet*3presentations%2Ehtm/_iI7?_t=tracking_disc]
You may want to add IBM Rational DOORS to your short list and – no matter which tool you chose – you may want to take an experienced consultant, at least, for the initial setup …
Hope that helps,
I’ve been told that we might need to validate the requirements management software in addition to our own software – I don’t know if this is true, but if so, it would be a big burden for a small start-up. Does anyone know if we need to validate that the requirements tool satisfies FDA 21 CFR Part 11 requirements for electronic records and electronic signatures?
Furthermore, what kind of ‘size’ are we talking about – i.e., is this a medical device company of any substantial size, potentially even with several globally distributed engineering locations?
@Nuno + all:
@Cindy + all:
Please, feel free to contact me if you are interested in more details, help, …
Dr. Bernd GRAHLMANN
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