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The Matrix Requirements Support team
Spend your time building Medical Devices, not on paperwork
Have your team maintain your device history file (DHF) while it is being designed, not before, not after. MatrixALM will help you to ensure the content is correct and support you in creating the documents for certification.
Have processes and work instructions which are simple, efficient and easy to use and improve, not SOPs written by someone else for someone else. MatrixQMS will help create a quality system which works for you, not against you.
Risk management needs to be integrated in the design process and the quality system, not in some Excel file on some server. With our applications, the risks are part of the traceability matrix.
Plan and document your verification and validation activities while you design your device, not once you think you are ready to release. MatrixALM provides the full traceability matrix from the requirements until the executed tests.
This is your average support rate you gave to us via JIRA Service Desk.
We are always here to help you!
MatrixRequirements greatly helped us obtaining the 510k clearance.
The tool itself was mandatory in providing the traceability from our requirements to our tests as easily as using just few clicks. And the neverending and always friendly team support is alone a great plus
We do regular changes and updates to our risk file.
Before Matrix such an iteration would involve 3 people, take 8 hours of actual clocked time and be completed in 3 weeks calendar time. Now a similar iteration takes 2 to 3 hours actual work and is completed in 2 days (with fewer errors and inconsistencies, less reference checking)
Upon suggestion the feature was immediately implemented in test/acceptance environment saving us a lot of time (and irritation) on the process of copy-pasting information.
I am working as a consultant helping clients master systems engineering tasks and especially requirements engineering with a focus on developing high quality requirement expressions and establishing end-to-end traceability using the V-model. This was my first experience of Matrix ALM and I just want to tell you how impressed I am. It is the first ALM solution I have tried that is truly usable out-of-the-box without customizations which I find being a key driving requirement for small and medium enterprises regardless of business area.
Nous sommes ravis de l'utilisation de la plateforme
Yes, the 510(k) was a success. I was very fortunate that the guys had the information so well organized. I believe it was your tool that helped tremendously in that success.
When in need of filing regulatory documents, we are simply ready to supply the external regulatory consultants with an orderly and highly accessible data set ... lowering our costs and getting things done faster.
The tool is powerful and has proven to be an asset to our product development. I would highly recommend the product... I also commend the Matrix Medical team on the customer support.
MatrixALM provides a high degree of flexibility that allows fitting the exact needs of customers.... At Eff'Innov Technologies, we adopted this tool whenever the project complexity cannot be tackled using traditional hand-made documentation and traceability hooks.
Ihr Matrix Requirements Produkt finde ich konkurrenzlos!
From discovering Matrix Requirement, through implementation planning, validation planning, training, configuration, data import, validation testing, and reporting to first roll-out we spent less than 30 calendar days with 3 dedicated people involved. This was enabled through the world class on-boarding process at Matrix, and their fast and competent support, and not least, a transparent, easy-to use highly configurable system made for medical device design control.
Let me say again how much I like your product. I am the first in our company to go through a project with it and it has made life so much better. So, thank you!
I've looked at lots of requirements management tools and Matrix stands out for being streamlined and flexible
Personally I think yours is one of the best suppliers I've had the pleasure to work with yet... the responsiveness is just stellar!
Today we've had an audit by a big pharmaceutical group. I've shown them how we work with Matrix Requirements and they were really impressed (even by such simple things as the way you've implemented electronic signatures). So thanks a lot for this great tool you've created and the wonderful cooperation we get from you guys.
We've just had a 13485 stage 2 audit and the auditor said in the closing meeting "One of the best QMS applications I've seen"
Matrix was one of the key tools we used in the development of Luminopia One, and allowed us to generate design history file documentation with ease and confidence. Many of the outputs from Matrix were submitted as part of our FDA De Novo application, and provided a foundation for the first FDA-approval of a virtual reality based digital therapeutic.
It has been more than one year since we have using Matrix QMS software. Pleased to inform you that we have completely transited paper based QMS into digital. Last year we faced many regulatory audits, all online and onsite audits went smooth with Matrix and auditors were quite convenient with Matrix. I found document traceability is very easy and software is very flexible to accommodate all kinds of QMS and regulatory requirements.
