We will be attending the LSI - Emerging MedTech Summit taking place from March 20 to 23, at TheWaldorf Astoria Monarch Beach Resort & Club in beautiful Dana Point, California, USA.
This summit is an opportunity for leading innovators, active investors and committed strategics from the Medtech industry to partner and build next generation healthcare technologies.
Don't miss this opportunity to learn more about the subject and let us know if you are coming. We are looking forward to meet you there.
6th Annual European Medical Device And Diagnostic Quality Assurance & Control And Supplier Quality Management Conference
Don't miss the opportunity to learn more about the best strategies for developing sustainable quality management systems, continuing to be audit-ready, and enhancing interdepartmental collaboration for improved quality management practices, AND meet us there to talk about it! With experts from leading regulatory bodies, manufacturers, and technology innovators, you will network with your peers, and access a wealth of knowledge and advice on emerging global trends, regulatory challenges, and evolving requirements for effective compliance.
Contact us to organize our meeting there. We will be waiting for you at our stand!
MedTech Meetup 6th edition
27-Feb-2023
The MedTech Meetup aims at building bridges between the stakeholders of the Belgian MedTech industry: manufacturers, suppliers, representatives of the public sector, investors, notified bodies, ... all from the Brussels, Walloon and Flemish Regions.
The 6th edition will take place this March 16th in Brussels, Belgium.
Why attending?
Listen to inspiring speakers [AM Plenary session]
Learn from experts about specific topics [PM Workshops]
Be advised on your project by professionals [Expertise Corner]
Discover the solutions and services of 15 exhibitors
Exchange with your peers
Come and meet the Belgian #matrixreq team at our booth, and tell us if you are also attending!
Also attending? Contact us to arrange our meeting there.
MedinTechs
25-Feb-2023
This March 13th and 14th will take place the MedinTechs exhibition in Paris, France, and we will be present!
Open to all, this exhibition brings together the health ecosystem, experts in new technologies and citizens.
So contact us if you are also going to arrange a meeting there, we are looking forward to seeing you!
Arab Health 2023
27-Jan-2023
We will be present at Arab Health, that will take place this January 30th to February 2nd, in Dubai World Trade Centre, United Arab Emirates.
If you are also coming, do not hesitate to tell us, and we can arrange a meeting there. Take the chance to meet our CEO - Eric Horesnyi, and some of the #matrixreq team.
All the significant questions and issues surrounding digital healthcare will be discussed. This conference brings together the key players in digital health and those who want to become one to rethink healthcare together and network.
Come meet us there, and contact us before to organize our meeting there.
Viv HealthTech
24-Nov-2022
This November 29th and 30th will take place the Viv HealthTech in Bordeaux, France.
This event, dedicated to the health sectorand technological innovation, offers you a new exclusive program of conferences, workshops and training organized according to 6 areas of expertise.
Feel free to contact us to arrange a meeting there, we are looking forward to seeing you there!
MEDICA 2022
10-Nov-2022
Matrix Requirements will be present at MEDICA, that will take place this 14-17 November 2022, in Düsseldorf, Germany.
If you are also coming, do not hesitate to tell us, and we can arrange a meeting there. Take the chance to meet our new CEO - Eric Horesnyi, the Co-founder - Yves Berquin and some of the #matrixreq team.
We are looking forward to meet you there!
MedTech Twente Week 2022
31-Oct-2022
We will be attending the MedTech Twente Week that will take place this 2 - 4 November, 2022 at Twente, Netherlands.
We will be present on site during the first 2 days, so contact us if you want to meet us there.
The Matrix Requirements team is looking forward to talking to you.
We will be attending MedFit 6th edition, the leading European partnering event that gives the opportunity to connect with international key innovators in the MedTech, diagnostic and digital health sectors, on September 20th & 21st, in Grenoble, France.
Come and meet us stand F9, we look forward to seeing you.
Do not hesitate also to Contact us to organize our meeting there to have a discussion or a live demo of MatrixALM or MatrixQMS.
VDE Symposium
16-Sep-2022
This September 20th will take place the VDE Symposium - Cybersecurity in the Life Cycle of Medical Devices, in Frankfurt, Germany.
Do not hesitate to Contact us if you want to meet there.
We look forward to seeing you.
MedTech X Digital
06-Sep-2022
We will be at MedTech X Digital this September 14th & 15th, in Frankfurt, Germany. The event for the digitalization of product lifecycle processes in the IVD & Medical Technology industry.
Do not hesitate to Contact us if you want to meet there. We look forward to seeing you.
Welcoming Lauxera Capital Partners
16-Jun-2022
With the help of Lauxera, we are able to grow faster and keep supporting our customers with new products and tools with the same dedication we showed until now.
Our amazing team members will all stay onboard and are looking forward to integrating new colleagues!
We will be hiring in all departments, contact us for details or stay tuned to our news here and on LinkedIn.
This event will bring together once again all the startups related to Medtech and their ecosystem at the Cité des Sciences, Paris 19e in France. Conferences and workshops on the startups' journeys and the many challenges they face, innovation and employment & skills areas as well as B2B meetings will make up this 7th edition.
Matrix Requirements is looking forward to sharing its knowledge during this day.
ISO 13485 Audit
ISO 13485 Audit
28-Mar-2022
Matrix Requirements is proud to announce the successful audit of its own EN ISO13485:2016Quality Management System!
Our commitment to quality is key. In this remote audit we used MatrixALM and MatrixQMS applications to get our ISO 13485 and ISO 27001 quality system certified, and being able to do the audit paperless helped a lot to make it pass smoothly.
If you want to know more about our products, MatrixALM and MatrixQMS, do not hesitate to contact us or subscribe directly for a demo.
Medi'Nov Connection
21-Mar-2022
We will be attending the Médi'Nov Connection 10th edition, the major event for decision makers in the MedTech industry, the 30 & 31 March, in Lyon, France.
Do not hesitate to Contact us if you want to meet us there and have a discussion or a live demo of MatrixALM or MatrixQMS.
It is a unique event in Belgium 100% focusing on MedicalDevices, IVD Medical Devices and DigitalHealth. This Meetup gathers every year the Belgian medtech ecosystem to give its stakeholders the opportunity to MEET and LEARN from each other. There is always plenary talks, workshops and an exhibition. Inspiring speakers also that share their experience and expertise on the Medical Device world.
We will be glad to see you there and have the opportunity of learning and networking, but also of gathering.
Don't hesitate to contact us if you want to take the opportunity to have a discussion or a live demo of MatrixALM or MatrixQMS.
We are looking forward to meet you.
Release 2.3
MatrixALM and MatrixQMS 2.3
30-Jun-2021
Matrix Requirements is happy to announce the version 2.3 of MatrixALM and MatrixQMS.
The new release introduces many new features and improvements. The most important are:
New Module: branch and merge, allowing you to create branch(es) of your project and merge later into the mainline.
New Module: translation module, to automate translation of specific field(s) from one language to another.
More flexibility documenting: the new report engine allows to create custom tables for PDFs or Excel as well as custom rendering of item content with complex logic and formatting.
Automatic emails to summarize the pending notifications
Extra configurations available in the Administration side
Improvements training dashboard with onboarding wizard.
Publication history Dashboard for MatrixQMS,
New possibility to reject Signatures
UI improvements and some bug fixes
...
and this is only a high summary of the changes, to see all the changes belonging to this version, feel free to download the 2.3 Release Notes
ISO 13485 Renewal
EN ISO 13485:2016 certification renewal
14-Jan-2021
Matrix Requirements is proud to announce the successful audit for the certification renewal of its own EN ISO 13485:2016 Quality Management System, with not a single non-conformity!
Our commitment to quality is key. In this remote audit we used MatrixALM and MatrixQMS applications to get our ISO 13485 and ISO 27001 quality system certified, and being able to do the audit paperless helped a lot to make it pass smoothly.
Interested to know how MatrixALM and MatrixQMS applications works? Don't hesitate to reach out!
Release 2.2
MatrixALM and MatrixQMS 2.2
22-Jan-2020
Matrix Requirements is happy to announce the version 2.2 of MatrixALM and MatrixQMS.
The new release introduces many new features and improvements. The most important are:
A fresh and smooth design to make the use of Matrix even easier than before.
A notification system with automatic notifications created when Matrix users have specific tasks to perform (signatures, review,..). This feature can also be used to manually create some tasks between users.
The system now indicates that other users are looking at the same item. Once one person starts editing, the item will be read-only for others and updated once it is saved.
New dashboards are available to have quick overview of the test executions, traceability, notifications, or reviews but also your personalized dashboard with all the work assigned to you
The review module got improved to include inline annotations for the reviewed items.
The possibility to create multiple risk layers within the same project allowing you to make different configurations of your risk analysis for your product (e.g. for research and development vs production risks).
A group management feature, giving you the opportunity to create groups of users to faster assign, select, manage access, or notify a group of users.
PDFs from external sources can now be easily signed within Matrix by adding a signature page to it.
In MatrixQMS, you can also manage the training of all your employees regarding internal processes and work instructions.
In MatrixQMS, you can add other publishable layers than traditional PROC and WI layers.
and this is only a high summary of the changes, to see all the changes belonging to this version, feel free to download the 2.2 Release Notes
Don't hesitate to contact us if you want to take the opportunity to have a discussion or a live demo of MatrixALM or MatrixQMS.
We are looking forward to meet you.
Inter-university biomedical engineering day
18-Oct-2019
We are presenting our application and providing practical workshop to the biomedical engineers of tomorrow during the Inter-university biomedical engineering day.
This event will take place at UCLouvain (campus Louvain-la-Neuve) on Wednesday, October 30th, 2019.
This three-day series is co-organized with ULB and ULiège.
A nice initiative from Universities to put in contact students with industries!
ISO 27001
EN ISO 27001 Certificate passed audit
07-May-2019
Matrix Requirements is proud to announce the successful audit of its own ISO 27001 Information Security Management System. As a provider of software solutions which can be used in the cloud, security management was always a key concern for us. From the first day on, we designed the software to be be used in this environment:
All access is done through secured protocols
We have procedures to keep our software and servers on the latest state of security
Our product and operation risk analysis covers cybersecurity issues
We use modern encryption methods to store sensitive data
As part of our quality system we control who has access to which data and how it is secured
Our software is part of a bug bounty program (YesWeHack)
Since we had all this in place anyway, we decided that we want our security procedures reviewed based on the ISO/IEC 27001:2013 by external auditors and a notified body. As a result we got our certificate to comply with the standard. Here's how we achieved compliance in a short time (Blog - How we integrated ISO 27001 requirements into our QMS.)
Release 2.1
MatrixALM and MatrixQMS 2.1
26-Dec-2018
Matrix Requirements is happy to announce the version 2.1 of MatrixALM and MatrixQMS.
The new release introduces a series of improvements and new features. The most important are:
A new module for performing reviews allowing you to define comprehensive reviews of selected items by a group of reviewers. These reviews can be applied to MatrixALM (review of requirements, risks, ...) or MatrixQMS (review of processes, risks, ...)
Redlining allowing you to compare any two versions of a document.
Possibility to see a list of changes between two given dates as well as browsing the project as it was at some date in the past.
Excel import
Integration with Slack
New MRQL searches to easily find specific information on risks, tests, folders and within the full traceability
Allow filling document sections based on search expressions
We also introduce the Enterprise version of Matrix, tailored at medium and big teams: it includes all features of MatrixALM and MatrixQMS and offers a variety of hosting offers, including intranet.
Don't hesitate to contact us if you want to take this opportunity to have a discussion or a live demo of MatrixALM or MatrixQMS.
We are looking forward to meet you.
Release 2.0
MatrixQMS and MatrixALM 2.0
12-Mar-2018
Matrix Requirements announces Version 2.0 of its flagship product MatrixALM, and the release of the new product MatrixQMS. MatrixQMS builds on the same engine as MatrixALM to allow companies to manage their QMS entirely in Matrix including:
Management of the standards you have to follow - and their Gap Analysis
Links from the standards clauses to the processes
Links from the processes to work instructions
Risk analysis of the processes, Risk controls, and link to other processes as Risk Controls
Maintenance of all the records:
CAPAs
QMS forms (meetings, ...)
HR forms
Both products now also include new features such as Access Control Lists (ACL) and Gates. MatrixALM is the new name of Matrix Requirements Medical.
Matrix Requirements is proud to announce the successful audit of its own EN ISO 13485:2016 Quality Management System, with not a single non-conformity. We did this not only to show our commitment to Quality but also to validate our new product MatrixQMS soon to be released. MatrixQMS uses Matrix Requirements Medical‘s core engine to
Manage processes and work instructions
Make gap analysis against standards
Perform a risk analysis of all processes
Manage CAPAs
Manage all quality-related records
Once the processes are defined they can be reviewed and published to the whole company Ask us for a sneak preview!
510(k) Workshop organized by the Medical Device Academy
11-Oct-2017
In the 510(k) workshop, October 11th-12th Matrix Requirements will talk about software validation and IEC 62304 in general. We are looking forward to meet the participants and demonstrate Matrix Requirements Medical and its ability to simplify the maintenance of the design documentation of Medical devices.
You can find more about the workshop and registration here
Release 1.11
Matrix Requirements Medical 1.11
21-Aug-2017
Matrix Requirements announces Version 1.11 of its flagship product Matrix Requirements Medical. The new version brings many new features and improvements, including:
Ability to import Word documents to be used as controlled documents
Matrix Requirement is proud to announce the FDA Clearance of Mindmaze's MindMotion Pro, a VR rehabilitation platform. Mindmaze, the only European medical device unicorn, uses Matrix Requirements Medical for its technical documentation, which allowed them to generate the entire Design History File for a successful FDA 510(k) submission.
Intermeditech
05-May-2017
Matrix Requirements sera présente au salon Intermeditech du 16 au 18 mai à Paris - Porte de Versailles - Pavillon 1 dans le cadre de la Paris Healthcare Week. Nous partageons le stand avec un des nos clients, FCE Polycaptil qui utilise avec succès notre application. Stand F9
Matrix Requirements is proud to exhibit at the RAMD2017 congress on May 15th and 16th, 2017 in Amsterdam. We are looking forward to meet the participants and demonstrate Matrix Requirements Medical and its ability to simplify the maintenance of the design documentation of Medical devices.
Matrix Requirements sponsors Software Design for Medical Devices conference in Munich
03-Mar-2017
SDMD is a conference specialized in hands-on lectures about agile software development for medical devices. We will be showcasing Matrix Requirement Medical during the two main conference days 22nd and 23rd of February, 2016
Release 1.10
Matrix Requirements Medical 1.10
21-Jan-2017
Matrix Requirements announces Version 1.10 of Matrix Requirement Medical. This release has many new features and improvements. These are the highlights:
Document generation
Support of table of contents showing items
Support of index show items
Sorting of items by id (rather by order in tree)
Administration client shows an overview page with which user has access to which project
Matrix Requirements announces Version 1.9 of Matrix Requirement Medical. This release has many new features and improvements. These are the highlights:
Miracle search expression (allow you to search by field, date, etc.),
Search results can be shown in list view
Context pages give additional information for selected items
Many new documentation features
Possibility to re-use tests steps in multiple test cases
2016 Product Realization Group Hardware Symposium and BBQ
17-Sep-2016
Matrix Requirements is sponsoring this year's hardware symposium. Product Realization Group's (PRG's) Hardware Symposium is your opportunity to learn about the latest hardware trends from industry experts and network with other hardware professionals in an informal setting at Silicon Valleys' iconic Computer History Museum.
During this event you will:
Understand how to design products for behavioral change
Learn about the future of hardware from our expert panel
Network with other hardware professionals, investors, PRG members & sponsors
Enjoy award winning BBQ brought to you by Chef Rodney Baca
Experience 10 new hardware product demos
... and see Matrix Requirements Medical in action!
Release 1.8
Matrix Requirements Medical 1.8
03-Mar-2016
Matrix Requirements announces Version 1.8 of Matrix Requirements Medical. This release has many new features and improvements. These are the highlights:
A new JIRA server integration,
Custom controlled documents with your own style sheets are possible
Project branching (in the past) and cloning is now possible
Matrix Requirements announces collaboration agreement with Springborne Life Sciences, a partner company of the Product Realization Group (PRG)
11-Nov-2015
Matrix Requirements has signed a collaboration agreement with Springborne Life Sciences, a partner company of the Product Realization Group (PRG) which is a consortium of Silicon Valley companies that takes hardware products from idea to scale. Springborne provides expert services in medical device development and regulatory compliance. Dr. Geetha Rao, CEO of Springborne stated that "the Matrix Requirements Medical software offers an exceptionally effective tool for managing design requirements and deploying lean and accelerated methods for medical device development". Mike Keer, CEO of PRG stated that "we look forward to working with the Matrix team to deliver a lean and compliant software platform that covers the entire Medical Device product lifecycle. By leveraging Springborne's proprietary architecture, PRG is now able to combine with existing services to deliver faster time to market at substantially lower risk and cost for clients. This is a huge market opportunity that we are excited to grow! " Wolfgang Huber and Yves Berquin, founders of Matrix Requirements are very enthusiastic about the opportunities of the shared offering and the professionalism provided by Springborne and PRG in providing their customers with the best possible tools and methods: "We are confident that the collaboration will give us a privileged access to the very strong medical device industry in California."
Release 1.7
Matrix Requirements Medical 1.7
09-Oct-2015
Matrix Requirements announces Version 1.7 of Matrix Requirement Medical. This release has many new features and improvements. These are the highlights:
Review workflows.
You can compare two or more revisions of an item in the history dialog.
The system can send emails, e.g. to request document signatures.
You can use smart links and JIRA tickets in test steps.
When creating test runs, you can pre‐set some values, like tester or version number.
A new JIRA plug‐in allows to more easily link items.
You can see the documentation status in the new documentation dashboard.
We are proud to share with you that our customer R-Action successfully certified its first product:
The technical file was compiled in less than two months based on our existing documentation. After submitting it we had only minor corrections to do which was easy since all the data already existed in Matrix.
During the audit we even got praised for our change control process and our dedication to quality.
Matrix Requirements announces Version 1.6 of Matrix Requirement Medical. This release has many new features and improvements. These are the highlights:
Creation and management of controlled documents has become easier, e.g. with text blocks which can be re‐used
The reference dialog now allows to select existing up and down links
Drag and drop support: you can drag images or files into rich text controls or into the file attachment control.
Several new reports allow you to review the project status more quickly
References indicate by a small icon whether the referenced item might be outdated
Matrix Requirements offers a pre-configured Tool Validation Project to its customers
01-Jul-2015
According to FDA regulations (Part 820.70) any software used in the production of medical devices must be validated. To simplify this task Matrix Requirements developed a specific project template. The white paper below summarizes the regulatory requirements and proposes a method to do this using MatrixALM. Please contact us if you want to know more about this free offer.
Matrix Requirements wins the Boostcamp competition of the MIC Brussels
16-Jun-2015
Boostcamp is a biannual initiative of the Microsoft Innovation Center (MIC) that aims at helping Information Technology (IT) startups. The MIC is a public-private partnership between the Brussels-Capital Region and private companies, Microsoft being the main partner. Its objective is to create 50 jobs a year in the new technologies sector. At the onset of this 7th edition, 24 startups entered the race. At Tuesdays final, 4 of them were still in contention. Eventually, a jury comprised business professionals, emerging technologies specialists and private investors selected Matrix Requirements as the grand winner! For more information on MIC, please visit http://www.mic-brussels.be
Release 1.5
Matrix Requirements Medical 1.5
26-Mar-2015
Matrix Requirements announces Version 1.5 of Matrix Requirement Medical. This release has many new features and improvements and is introducing Variants With Variants you can now document different variants of your product in the same project, reusing the common requirements or specifications, and defining specific elements for the different product variants. An example would be product which has different packaging or shelf life requirements in the US versus Europe. Examples of Variations used by our customers during beta testing:
FDA and CE markets. A lot of requirements are common (it's the same basic product) but labeling and intended use are different. Some requirements, specifications and tests are specific to the US market and to the CE marked product. OTC (over the counter) or Professional ‐ if you sell a medical product with different intended use depending on the distribution channel and intended audience.
Smoke ‐ Regression ‐ General tests: Quickly select a list of tests that are all over the place in the tree, but have in common the fact that they are smoke tests (to be done early) or regression tests (to be done last).
Releases ‐ Define different versions. Now you can generate the whole documentation for each release, and re‐use all the common requirements, specifications, tests.
Possibilities are endless and make the whole documentation process much simpler when you are in a situation involving a variant. The whole elements tree is filtered with the click of a button to only show the relevant items to a particular variant. All documents can be produced with a given set of variants, including traceability reports and Design History Files documents.
Matrix Requirements announces Version 1.4 of Matrix Requirement Medical. This release has many new features and improvements. These are the highlights: With Variants you can now document different variants of your product in the same project, reusing the common requirements or specifications, and defining specific elements for the different product variants. An example would be product which has different packaging or shelf life requirements in the US versus Europe. Examples of Variations used by our customers during beta testing:
FDA and CE markets. A lot of requirements are common (it's the same basic product) but labeling and intended use are different. Some requirements, specifications and tests are specific to the US market and to the CE marked product. OTC (over the counter) or Professional ‐ if you sell a medical product with different intended use depending on the distribution channel and intended audience.
Smoke ‐ Regression ‐ General tests: Quickly select a list of tests that are all over the place in the tree, but have in common the fact that they are smoke tests (to be done early) or regression tests (to be done last).
Releases ‐ Define different versions. Now you can generate the whole documentation for each release, and re‐use all the common requirements, specifications, tests.
Possibilities are endless and make the whole documentation process much simpler when you are in a situation involving a variant. The whole elements tree is filtered with the click of a button to only show the relevant items to a particular variant. All documents can be produced with a given set of variants, including traceability reports and Design History Files documents.
Matrix Requirements announces Version 1.3 of Matrix Requirement Medical. This release has many new features and improvements and introduces electronic signatures: With Electronic Signatures Matrix Requirements Medical now fully supports FDA CRF part 11. Electronic signatures allow you to quickly sign documents online.
New controlled documents allow to easily create documents for the technical file, the design history file, device master record, etc. Other highlights are:
Out‐of‐date warnings indicate if someone else is working on the same design item.
Full Word and PDF support for all reports and documents
Many new and improved reports
Release 1.1
Matrix Requirements Medical 1.1
24-Oct-2014
Matrix Requirements announces Version 1.1 of Matrix Requirement Medical. This release has many new features and improvements. These are the highlights:
Live out‐of‐date trace indication allow to fix traceability issues quickly
Suspicious trace lists in reports show traces which might be out‐of‐date
Design reviews for design items allow to mark items as reviewed
Smart links allow to refer to other design items in rich text boxes, by just typing the id
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