MedTech Meetup 2022

Belgium benefits from a vibrant ecosystem federated around digital health and AI technology. The AI4Health workgroup of AI4Belgium has federated the Belgian health to push forward the boundaries of AI adoption. In this talk, Giovanni Briganti will outline the main aspects of hospital adoption of AI in Belgium from a nationwide study results as well as the steps needed to move forward.

Hospital networks… a hot topic, and this will only become hotter and hotter in the upcoming years. In general, it is about hospitals working together to provide high-quality and efficient care. Investments in collaboration are important, especially in secure and future-proof IT solutions. How can we exchange information? And with who? What about tracking our healthcare providers and patients inside our network? Should we already think about international information exchange? Let’s address these questions together, based on experience from other countries and based on the Master Patient Index-use case.

Healthcare was at the center of attention during the last year and a half due to the COVID pandemic. It made us aware of the outstanding quality of our system and at the same time its limitations. Together with the accelerated digital transformation in the sector, we are at an important crossroad and need to ask fundamental questions on how we deliver care. During this session we explore the possibilities of telemedicine and how it can increase the capacity of our care system whilst maintaining the same level of quality.

Matrix Requirements offers solutions for medical device companies to manage their design history file and quality system more efficiently:

• MatrixALM helps bridging the gap between agile development and an up-to-date and correct technical file for medical devices
• MatrixQMS helps you to build and maintain your quality system more efficiently

MatrixALM makes it easy and efficient to manage your specifications, risks and tests. All in one place.

With MatrixALM you can instantly start managing your medical device requirements, use cases, specifications, risks and tests in one intuitive application. Without any training or setup needed, you will be able to quickly ensure full traceability and compliance to standards.

MatrixALM does the hard work for you. It helps your development team – by allowing them to concentrate on what they do best, and your quality team – by building the robust and accurate documentation needed at the same time. MatrixALM provides a seamless and always available single source of truth at any time to all your team members.

You can quickly create reports for your technical file and Design History File, preparing you and your team for any (unannounced) audits. MatrixALM is easy to use and gives you total control through revision history and audit trails. It allows you to efficiently create your documents for CE certification and FDA approval.

Key assets:

• Requirement management
• Risk management
• Test management
• Project management
• Technical documentation
• Electronic signatures (Part 11 compliant)
• Manage versions & product variations
• Branching project and merging back capabilities when necessary

MatrixQMS makes it more efficient to create and maintain your Quality System.

With MatrixQMS you can document your procedures/SOPs, work instructions, process risks and all records, like CAPAs, meetings, audit, supplier approvals, complaints,…

The Gap analysis to show compliance of any standard or regulation with your internal procedures can easily be demonstrated through traceability between the standard and your procedures entered in MatrixQMS.

Through this traceability to the requirements of the standards like ISO 13485, you will also be able to understand the existing processes better and be able to update them faster as all the reviews and approvals are done online.

MatrixQMS allows you to publish your quality system to the team including trainings needed to be completed by the relevant staff. These trainings can be followed up and managed for the entire team via a global dashboard.

Key assets:

• Traceability from regulation to your QMS
• Paperless processes and work instructions
• Risk management
• Included training module
• CAPAs and any other records
• Forms/template management

Learn more on Matrix Requirements website.

Telemonitoring is becoming an essential part of our healthcare but there are challenges to fit it into our current healthcare system. What needs to change to do so? We would like to bring our vision as a conversation starter to anyone who is currently active in healthcare.

Medical Device Regulation is one of the most important changes currently affecting our industry, but also the operations of a Notified Body. At SGS, recently designated for MDR with a very wide scope, the main effect of MDR relates to resources and planning. With this presentation, we aim at providing insight in how the MDR has and will change our operations and providing a general overview of how this relates to manufacturers, their products and finally the patients.