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UDI: what does it mean for your product and your QMS?

posted on 24-Nov-2021 by ann
Unique Device Identification or UDI is one of the changes that have been introduced by the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). This article gives an overview of what UDI means and the implications to the Quality Management System (QMS).

How to do a gap analysis for MDSAP requirements

posted on 22-Sep-2021 by ann
Compliance with requirements from several legislations, is a burden for organizations. Regulators recognize this as well and created the Medical Device Single Audit Program to address this issue in a certain way. MatrixQMS is flexible enough to cope with MDSAP and to give an overview on how you comply to different requirements and legislations in an easy way.

How to transition smoothly from an existing QMS

posted on 11-Aug-2021 by arnaud
When you have a paper-based QMS system in place, you often wonder what would be the effort of transferring the information into a digital system. Different ways exist to transfer your actual system into an eQMS and in all the proposed scenarios, you can be quickly operational.

A QMS is a waste of time. Or perhaps not

posted on 23-Jun-2021 by yves
OVH Fire: we had a real life experience with a disaster recovery plan. QMS/ISMS put to the test!

Case Study: Matrix Requirements and Neocis

posted on 25-May-2021 by 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.

What is an electronic QMS?

posted on 11-May-2021 by ann
What are the differences between a paper-based QMS and an electronic QMS? Is it worth the effort of making the switch? This blog post gives you an overview of the advantages and disadvantages.

Information Overflow - Do too many productivity tools kill the productivity?

posted on 18-Mar-2021 by wolfgang
Often we get the request to send emails for all kind of events. We don't think this is the most efficient ways to deal with managing work. Emails should be send by humans not robots. Robots are much more clever: they can actually maintain todo lists for you!

Why SOUP can go bad

posted on 24-Feb-2021 by wolfgang
This story shows how even standard libraries used in millions of products can have very unexpected issues.

Getting started with a QMS from scratch: How and why do I do internal audits

posted on 05-Jan-2021 by ann
Once you are done setting up a QMS and you started to actually implement it, it's time for the next part in the Plan-Do-Check-Act cycle. You should check whether your QMS is working in an effective way. One tool to do so, is to perform internal audits.

What is required for validation of software used in QMS processes?

posted on 16-Nov-2020 by ann
Software used in QMS processes needs to be validated according to ISO 13485 and FDA part 820. This article describes what software falls under this category, to which extend it needs to be validated, and what methods and standards can be applied to validate it.

Getting started with a QMS from scratch: What are records and where and how do I store them?

posted on 20-Oct-2020 by ann
A Quality Management System does not only contain procedures and work instructions which tell you what to do. It also contains records which are the output from those procedures and work instructions. This post focuses on how records can be created and controlled using MatrixQMS.

Getting started with a QMS from scratch: releasing processes and training people on them

posted on 01-Oct-2020 by ann
Change control is key in any QMS. Using an electronic QMS offers more possibilities when compared to a paper based system. This blog describes how MatrixQMS handles version control, release and training within processes and work instructions.

MDR update: where are we now?

posted on 11-Sep-2020 by ann
This blog post gives an overview of information we could find about the MDR transition status. It's mainly focussing on timelines, EUDAMED implementation and Notified Bodies. This update is focused on news about the EUDAMED Actor Registration module to obtain a Single Registration Number (SRN), harmonized standards under the MDR and IVDR and the number of Notified Bodies accredited for the MDR and IVDR.

Getting started with a QMS from scratch: risk-based approach for processes

posted on 09-Sep-2020 by ann
EN ISO 13485:2016 requires you to adopt a risk-based approach, not only for product development but as well for your entire QMS. In this article we explain a bit more what this means for a QMS and its processes.

Getting started with a QMS from scratch: organizing an efficient review process

posted on 03-Jun-2020 by ann
Once a document, process, procedure, etc is written, it needs to be reviewed and approved. An electronic QMS, like MatrixQMS, can help to organize and document this in an efficient way.

MDR Update: Proposal to postpone Date of Application MDR

posted on 26-Mar-2020 by ann
This blog post gives an overview of information we could find about the MDR transition status. It's mainly focussing on timelines, EUDAMED implementation and Notified Bodies. This update is focused on the proposal to delay the date of application of the MDR by one year.

Getting started with a QMS from scratch: Start to write processes...and never stop!

posted on 17-Mar-2020 by ann
When creating a QMS from scratch, you need to decide which processes or procedures to write first and how to approach this. In the second post of this series we focus more on how to write processes and where to start.

Getting started with a QMS from scratch: 3 key questions to ask yourself at the start

posted on 09-Mar-2020 by ann
Bringing a medical device to the market implies setting up a Quality Management System. When starting from scratch, the first things to take into account are the regulatory requirements, the role of your organization, the scope of your QMS and the structure of your QMS. This is the first post in a series on how to get started building a QMS.

Ouuh there are two current versions of the same standard - which one do I choose?

posted on 20-Feb-2020 by ann
Depending on your market, different versions of the same standard might be applicable to your product or organization. For example, EN ISO 14971:2012 is the harmonized standard in Europe while ISO 14971:2019 is the consensus standard in the US. Which one should you choose?

MDR - News from Europe regarding Notified Bodies

posted on 07-Feb-2020 by ann
This blog post gives an overview of information we could find about the MDR transition status. It's mainly focussing on timelines, EUDAMED implementation and Notified Bodies, unless anything else that's new and exciting pops up. This update is focused on the state-of-play documentation regarding the NBs accreditation for the MDR and IVDR.

4 things Swiss manufacturers should consider in preparation for the MDR

posted on 03-Feb-2020 by ann
Currently the trade of medical devices between the EU and Switzerland is regulated through a Mutual Recognition Agreement (MRA). However, this MRA has not been updated to be valid in combination with the Medical Device Regulation (MDR). What is the impact on Swiss manufacturers?

What are the 3 main changes in the new ISO 14971 version?

posted on 20-Dec-2019 by ann
This post describes the 3 main changes in the new version of ISO 14971. It focuses on new/adapted definition, risk acceptability and ISO/TR 24971

MDR - Ready, Steady, GO? - Update 2

posted on 05-Dec-2019 by ann
This blog post gives an overview of information we could find about the MDR transition status. It's mainly focussing on timelines, EUDAMED implementation and Notified Bodies, unless anything else that's new and exciting pops up...

Is your software fit for regulation under the MDR?

posted on 21-Nov-2019 by ann
Software is taking a more prominent role in medical device legislation all over the world. Matrix Requirements recently presented on this topic at the Biolago Academy event.

MDR - Ready, Steady, GO? - Update

posted on 12-Nov-2019 by ann
This blog post gives an overview of information we could find about the MDR transition status. It's mainly focussing on EUDAMED implementation and Notified Bodies, unless anything else that's new and exciting pops up...

MDR - Ready, Steady, GO?

posted on 09-Oct-2019 by ann
This blog gives an overview of the information currently available about the MDR transition status. It's mainly focussing on EUDAMED implementation and Notified Bodies, unless anything else that's new and exciting pops up...

FDA's new guidance on Software Functions and Mobile Medical Applications

posted on 04-Oct-2019 by ann
This post is a summary of FDA's new guidance on Device Software Functions and Mobile Medical Applications, published on September 27th 2019.

From the US to the EU: How to help my medical device safely cross the Atlantic

posted on 27-Sep-2019 by ann
Both the US market as well as the EU market are highly regulated for medical devices. However, there are some specific things to take into account when crossing the Atlantic.

What you can do with our new Slack App!

posted on 28-Aug-2019 by tilman
How to enable and use the new Slack App for Matrix Requirements

How to validate QMS software efficiently?

posted on 22-Aug-2019 by ann
Software validation is required by different standards and legislation related to medical devices such as 21CFR Part 820 as well as ISO 13485. This also applies to software used in a QMS. Here we explain what is the most important when validating software used as part of the Quality Management System.

Is my Fitness app a medical device or not?

posted on 24-Jul-2019 by ann
For some products it might be clear that they are a medical device, but for some it's more difficult.

Standards: not one fit-for-all

posted on 12-Jun-2019 by ann
When you start a medical device company or you develop a new medical device, you need to know which standards might be applicable to your device. Here are some tips on what to look for and where.

The trinity of traceability

posted on 29-May-2019 by ann
Traceability is important from the very start of the design, during production and throughout the entire supply chain. Traceability is not a static linear connection between your requirements and test forms, it's a global concept, a matrix connecting the complete life-cycle of a product.

Our experience running a virtual company

posted on 17-May-2019 by yves
How Matrix Requirements is working as a virtual company. The tools and tricks we use to make it work!

Stop printing for your V&V testing!

posted on 06-May-2019 by arnaud
How to support rapid design iterations of medical devices while still maintaining systematic, rigorous V&V testing? In the recorded webinar, you will see the added value and the most efficient testing workflows using a modern SW tool like MatrixALM. Watch the recorded webinar here!

What has medical device design to do with a thousand year old game?

posted on 02-May-2019 by wolfgang
For hundreds of years there is a seemingly simple puzzle around - it's called Tangram. Well it's not that easy.

Will the new MDR result in a re-classification of your stand-alone software?

posted on 23-Apr-2019 by ann
The Medical Device Regulations (MDR) are coming closer and for some companies, they'll have a significant impact. Here we discuss the impact on stand-alone software classification.

What are the risks in doing Risk Management of your Medical Device in Excel ?

posted on 03-Apr-2019 by arnaud
How to keep the risk management process efficient with a fast moving product development? We show some practical examples in the following webinar. Watch the recorded webinar here!

Agile Design Reviews: Nightmare or Dream Come True ?

posted on 02-Apr-2019 by ann
Design reviews are an essential step in your design and development process. How can you manage them if you are using an Agile process where everything can and does change all the time?

How we integrated ISO 27001 requirements into our QMS ?

posted on 22-Mar-2019 by ann
In this blog post we want to share our experience with integrating an Information Security Management System based on ISO 27001 into our existing Quality Management System based on ISO 13485.

5 possible pitfalls when your procedures need to comply with different standards

posted on 15-Mar-2019 by ann
ISO 13485, ISO 9001, ISO 27001, ISO 14001 are all examples of standards in management systems. All of them are based on the same kind of principle, but they do have their own specific approaches and focuses. This blog gives you 5 things to pay attention to when integrating different management systems.

Can medical device software be updated and released in an Agile way ?

posted on 17-Feb-2019 by arnaud
What are the modern methods for Agile Design Controls for Medical Devices? We recently made a webinar explaining this and providing visual examples of Matrix Requirements application: MatrixALM. Watch the recorded webinar here!

When is a good time to switch from a paper-based to an electronic QMS ?

posted on 15-Jun-2018 by ann
For companies that are implementing a QMS from scratch, my advice would be to start immediately with an electronic QMS (eQMS). It will save you so much time, effort, frustration and money in the future! But what if you already have a paper-based QMS? And you are busy developing and improving your devices? And you have all these procedures in their nice binders (which nobody reads) and records in other binders. And the auditors seem to like it this way…

Does a QMS have to be static or can it be agile as well, is it worthwhile the effort going for it ?

posted on 03-Mar-2018 by ann
The QA department is like a zombie island. We all know about it, but we don’t want to go there. They seem to be living on dead paperwork. They have a thing called a QMS. It comes with rules and procedures, which never truly reflects the real way of working, but it’s just too much effort to change them…

ISO 13485:2016 - the new version has arrived!

posted on 24-Mar-2016 by wolfgang
Besides adding many details the main changes are that you need to do a risk assessment on all processes. The design and development requirements also have changed significantly, for example new requirements for the design transfer and design development files have been added. Another big change is that you have to validate software used to maintain your quality system.

IEC 62304 2015 - impact on Class A software

posted on 17-Mar-2016 by wolfgang
What changes for Class A software with the updates of 62304:2015?
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