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

Written by
Arnaud Alberts

Most of Medical Devices companies start to use Excel sheet(s) just to manage the Risk analysis of their product. Compared to this static approach, this webinar describes a dynamic methodology managing risk analysis and risk controls to keep up with fast moving product development teams. Learn some practical aspects on how to integrate risk management into your overall product development workflow using a cloud-based application like MatrixReq.

This webinar was realized in collaboration with Sunstone Pilot and brings together process and software experts to explain a more flexible and rigorous approach on Risk management than standalone spreadsheet methods. We explain how to get from an isolated spreadsheet with no traceability to a process complying with the ISO 14971 standards where the whole team can collaborate to easily update and control the risks during the complete design phase.

Written by
Arnaud Alberts
Chief Customer Advocate

Since childhood, Arnaud Alberts has been fascinated by life sciences and healthcare. After earning a degree in BioEngineering, he began his career as a QA Engineer at a medical device startup, developing embedded software for prostate cancer detection using ultrasound. His analytical approach and attention to detail led to successful quality testing and the implementation of a QMS, securing CE mark and ISO13485 certification. Arnaud’s expertise expanded through clinical trials, training healthcare professionals, and collaborating closely with urologists. This experience naturally transitioned him into product management, where he guided product strategy and development. In 2018, Arnaud joined Matrix One, helping the startup as a Growth Manager, then evolved to lead the Success and Support team as well as the Product for Matrix Requirements. Today, as Chief Customer Advocate, he ensures users have an exceptional experience and feeding strategic insights back into product development.

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