Matrix Requirements: MatrixALM Introduction

This video shows the basic principle of MatrixALM and how you can efficiently manage the Development of your Medical Device and its related documentation (DHF).

We’re proposing our solution to medical companies who want to facilitate their live regarding the documentation and the organization of the development of their device. We know quite well how the documentation management can be a hurdle. Being able to manage a full traceability in the design and the testing as well as managing risks and making all important documents to comply with ISO 14971, ISO 13485 and other standards is complicate and time consuming. That’s the reason why we’ve built our software for our own needs initially and now, since 2014, we propose it to companies that are in the same situation than us before.

MatrixALM is a fully customizable application allowing you to adapt to your needs and to manage within one software, an agile development and the full documentation management from the design input (all the Requirements of the product), until the design output and its test cases (Specifications, test forms and test results). You also have the possibility to manage the Risks related to the product which is mandatory to comply with the medical device ISO 14971 for example. All history, each version is kept and can be easily found back.

All this can be manage in one place with the easy possibilities to extract some reports and the full documentation of your Design History File (DHF) to pass your audit and get your product certified. Digital signature (CFR 21 Part 11 compliant) allows you to keep everything digitally and not to bother anymore with paper.

MatrixALM product is built by Matrix Requirements GmbH, an ISO 13485:2016 and ISO/IEC 27001:2013 company