11-Aug-2021 — arnaud

When some people are at the final step of their decision to go for MatrixQMS application, we often receive the following questions:

“How much time does it take to implement a QMS in MatrixQMS?”
“Is there an easy way to make the transition from our existing QMS?”

Unfortunately, the best answer to these questions is often “It depends…”.

Actually, it depends on multiple factors that are relative to your company:

23-Jun-2021 — yves

Who said having a Quality System is a waste of time?

We are a scaleup company, providing Application Lifecycle Management and Quality Management System application for Medical Devices company, on a SaaS platform. We started over 8 years ago, two focused software engineers, having decided that the little application they did for themselves could be very useful for a lot of other companies. We had very little budgets, no investors, and did not take a salary for 2 years. The future was bright.

Having lived in medical devices companies for a big part of our careers, we felt that the methods and structure of this world was worth…

25-May-2021 — Arnaud

This case study was written by the R&D project engineer at Neocis Inc, a highly successful Miami-based medical device company that has been using Matrix Requirements applications for almost two years now. They explained why they chose Matrix, how and what data was transferred, and how they use Matrix on a day-to-day basis.

“As Neocis advanced further into the growth phase, we were quickly faced with the challenge of managing our requirements, risk and testing in an electronic database.

Having evaluated a number of options, Matrix Requirements was the tool of choice at Neocis. The criteria for…

11-May-2021 — Ann

What is the main difference between a paper-based QMS and an electronic QMS?

Why would you bother going from one to the other?

Is it worth the effort and the resources?

All valid questions and multiple possible answers…

Paper-based QMS

A paper-based QMS is the “traditional” way of documenting a Quality Management System. You have a specific set of approximately 20–30 procedures, a Quality Manual, and a bunch of forms. All of them written in Word and/or Excel.

The good news is: it can work. It has worked for many years. If you have someone that has the time…

18-Mar-2021 — wolfgang

Have you ever had the impression that something distracts you every few minutes?

More and more tools are used to manage work in companies. Most likely you are at this very moment using a task management and/or issue tracking software and perhaps some chat software. Maybe you are also chatting on Skype with customers, getting support emails from your help desk software or other information from your CRM?

Each of these and many more applications try to grab your attention, sending information about any change to you through as many channels as possible, even though they might not be of interest or relevance.

That has three main disadvantages:

1) you overlook that one important message.

24-Feb-2021 — wolfgang

What happened

One day we got an email from one of our customers:

“I cannot retrieve some document from the database anymore.”

We tried and true, our application just showed some unexpected error.

So we tried to understand what’s wrong

We didn’t…

05-Jan-2021 — Ann Vankrunkelsven

You have created all procedures, work instructions and templates. You have done a proper risk analysis on process level. Everything is reviewed and approved. People are trained and are working within and with the QMS.

Great! But the work is not yet done!

Setting up a QMS is one thing, however, the aim is to actually use it and maintain it. As mentioned in the previous posts of this series, the basic principle behind the ISO 13485 is Plan-Do-Check-Act. One way of checking is to perform internal audits.

Internal audits allow you to verify the implementation…

16-Nov-2020 — Ann Vankrunkelsven

If you are not quite sure what to do for software validation, you are not alone!

There are different standards explaining how to validate software products and some software seem impossible to validate at all. In this blog we will explain how to address this in a general matter and, as example, show you what it means when it comes to validating Matrix software.

Overview of regulations and standards

In the illustration above you see that the needs to validate software comes from mainly two places:

20-Oct-2020 — Ann Vankrunkelsven

As mentioned in the previous blog posts of this series, the main idea behind a QMS is the Plan-Do-Check-Act principle.

This means that you PLAN what you want to do, implement it and generate an output. Based on this output, you evaluate whether some things need to be improved.

Records are output from your QMS. They are a result from the DO phase and allow you to CHECK. Not only you can check and evaluate the effectiveness of your implementation.

Also auditors will check the records during their audits as it’s most of the time the…

01-Oct-2020 — Ann Vankrunkelsven

After you’ve written, reviewed and approved your processes and work instructions, you need to release them and make sure people are aware of the content.

This also needs to be done in a controlled and documented way, which means you’ll need to be able to provide records.

What does this mean?

How to approach this?

In a paper-based QMS…

Matrix Requirements

Spend your time building Medical Devices, not on paperwork.

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