Introducing Compose

Compose

Medtech lessons from the Trenches: Arnaud's stopry on QA Engineers in Medical Device Companies

Matrix Requirements Customer success manager story

Medtech lessons from the Trenches: A support engineer within Medical Devices with Eva

Matrix Requirements Support Engineer story

Explore the merging worlds of ALM and PLM in modern product development. Discover how they blend in SaMD, driving innovation for software-based medical devices.

Decoding ALM and PLM: Where Do They Diverge?

Decoding ALM and PLM: Where Do They Diverge

Discover the essential roadmap for pre-market medical device startups. From regulatory compliance and clinical validation to quality management systems and innovation strategies, uncover the 10 key steps to success in the competitive world of medical technology. Ensure patient well-being while navigating the complexities of regulations and innovation.

10 Essential Steps for Pre-Market Medical Device Startups

Medtech lessons from the Trenches: Breaking Barriers and Building Code with Iunia

Matrix Requirements Software Developer story

Elevate SxMD Success: Streamline Quality, Bridge Design Gap, Ensure Compliance. Discover the Power of Review & Approval Workflows in an eQMS.

The power of review and approval workflows in your eQMS

Medtech lessons from the Trenches: Ann's RAQA journey to Compliance

Matrix Requirements RA/QA story

To communicate about Software as Medical Device we need to understand the meaning of terms and abbreviations. A series of articles is here to explain the most commonly used terms and abbreviations. The first article focuses the terms of basic meaning for software as medical device: Health Software, Legacy Software, Medical Device Software, Software System, Software Item, Software Unit, SOUP, OTS, COTS.

SBOM, CBOM, OTS, COTS, SOUP - The complete guide

Matrix Requirements Co-founder story

How is medical device design changing? How is software as/in a medical device (SxMD) going to innovate in the future? Let’s answer these questions and more as we take a look into the future.

How Software is/as a Medical Device (SxMD) design & development is changing

Announcing our new look and feel

In order to ensure an organized and efficient software development process, it is imperative to maintain an up-to-date and well-documented software development plan. Learn all about what has to be covered by the software development plan.

Agile Compliance - Software development planning

The IMDRF Guidance on SBOM for medical device cybersecurity introduces a valuable framework for all stakeholders to ensure medical device cybersecurity, enabling documentation of Software content in a common way so a communication between software manufacturers and software users regarding cybersecurity relevant information becomes possible. It will allow manufacturers of Software as or in Medical Devices to implement SBOMs for their products and thus ensure conformity regarding regulative cybersecurity requirements - which also means to protect patients from undesired effects of software-controlled medical devices.

IMDRF published a new guidance on SBOM for medical device cybersecurity

Before starting to develop your software you need to write a software development plan. Learn how to achieve compliance with IEC 62304 while embracing the agile software development process....

Agile Compliance - Software Safety Classification

Europe moves ahead on AI regulation, Medical Device companies need to keep up

Navigating the MDR Maze: Unravelling Compliance Challenges for Legacy Medical Devices

Matrix Requirements helps thousands of medical device software developers (aka SaMD Software as Medical Device, SiMD Software in Medical Device or more generically SxMD) embrace the agile software development process. Join us as we jump into season 2 on the most important terms of IEC 62304 and their impact on agile development...

Agile Compliance - The 9 most important terms of IEC 62304 and what they mean for Agile Developers

Get Your Medical Device CE Marking Faster: Conformity Assessment by Notified Bodies.

How to Build a Culture of Compliance: Tips for Developing a Successful QMS

5 Reasons Against Using In-house Software Tools

Automated (UI) testing with Matrix Requirements

Traceability Matrix

Why does managing software requirements for medical devices differ from other industries?

FDA submissions, market access by comparison, do it with MatrixALM!

10 reasons why short test cases are better than bigger ones

Medtech Lessons from the Trenches - How not investing in an ALM and QM system derailed my cancer detection startup

Agile Compliance - Bridging the Testing Gap between Agile and Regulation in Medical Devices

Agile Compliance - Bridging the Requirements Gap between Agile and Regulation in Medical Devices

Agile Compliance - Bridging the Process Gap between Agile and Regulation in Medical Devices

3 of the most important regulatory topics to monitor during 2023

Agile Compliance - Agile Software Development explained for RAQA

Agile Compliance - IEC 62304 explained for agile teams

AI Act

Why Matrix Requirements fits with Agile

Postponed deadlines for MDR and IVDR

Calling time on paper: Why an eQMS is crucial for efficient MDR compliance

Pursuing Paperless in an Medical Device Landscape - Part 4

Pursuing Paperless in an Medical Device Landscape - Part 3

Pursuing Paperless in an Medical Device Landscape - Part 2

Pursuing Paperless in an Medical Device Landscape - Part 1

Control change without killing innovation

Proud of our support

Matrix Requirements statement on log4shell scare

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

How to do a gap analysis for MDSAP requirements

How to transition smoothly from an existing QMS

A QMS is a waste of time. Or perhaps not

Case Study: Matrix Requirements and Neocis

What is an electronic QMS?

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

Why SOUP can go bad

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

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

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

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

MDR update: where are we now?

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

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

MDR Update: Proposal to postpone Date of Application MDR

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

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

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

MDR - News from Europe regarding Notified Bodies

4 things Swiss manufacturers should consider in preparation for the MDR

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

MDR - Ready, Steady, GO? - Update 2

Is your software fit for regulation under the MDR?

MDR - Ready, Steady, GO? - Update

MDR - Ready, Steady, GO?

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

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

What you can do with our new Slack App!

How to validate QMS software efficiently?

Is my Fitness app a medical device or not?

Standards: not one fit-for-all

The trinity of traceability

Our experience running a virtual company

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

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

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

Agile Design Reviews: Nightmare or Dream Come True ?

How we integrated ISO 27001 requirements into our QMS ?

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

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

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

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

ISO 13485:2016 - the new version has arrived!

IEC 62304 2015 - impact on Class A software

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