Medical Device Risk Management training | next date: 23rd of September 2026
This full-day Medical Device Risk Management training is a deep dive into risk management according to EN ISO 14971:2019.
This training will help you gain in-depth knowledge on key topics, supporting your current or future medical device development.
Target group
- Researchers who want to translate their medical innovation, and right-size risk management for eventual product approval.
- Candidates who want to learn the core elements of Risk Management as applicable in Medical Device Development.
- Candidates with no to limited ISO experience who, professionally, will be directly involved in Medical Device Risk Management.
About the ISO 14971:2019
Medical device companies that develop and market their products must apply risk management, generally in line with ISO 14971. This international standard defines a structured process for identifying hazards, estimating and evaluating risks, controlling those risks, and monitoring effectiveness of risk management throughout the product lifecycle. The current version (ISO 14971:2019) strengthens lifecycle thinking, benefit–risk evaluation, and post-market feedback integration.
While further guidance (e.g. ISO/TR 24971) exists and continues to evolve, it can all be overwhelming to catch up with. This training prepares you to implement and maintain compliant end-to-end risk management processes and perform risk management for medical devices competently.
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Experts
Jean Blom – Quality Manager Medical Devices at Medace
Jean Blom is accountable for the daily quality assurance activities as Medace’s Quality Management Representative, and provides the strategy regarding medical device client planning, coordination, and execution.
He is the principal expert regarding quality requirements as defined by standards (ISO/IEC/EN), and their interactions with regulations such as the EU’s MDR (2017/745).
Before Medace, he worked hands-on in quality and regulatory for a start-up’s class IIA Active Diagnostic Medical Device, and as the quality systems-focused officer at a major multinational medical device developer and manufacturer in the ophthalmic surgery segment with a large variety of devices and operations; this provides him with a breadth and depth of experience that is both useful and familiar to Medace’s diverse client base.
Linda van Leeuwen – Regulatory Affairs Associate
Linda is responsible for supporting clients regarding the matters related to the regulatory compliance of their product and product development. This is achieved by advising, reviewing and teaching within client-focused projects, and by improvement and updates of the Medace QMS used for clients.
Linda has a BSc in biomedical research and has a vast amount of experience working for start-ups in the biomedical field. Before joining Medace she worked at one of the largest companies in ophthalmic surgery devices. There she was responsible for the regulatory side of product development and product changes, as well as regulatory intelligence, CE certification and 510(k) clearances, technical file maintenance of
ophthalmic surgery devices ranging from class I to class IIb, from reusable to sterile, from short-term use to implantable and active devices with software.
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About Medace
Medace supports academic groups and companies with innovative medical concepts in need of technical, quality and clinical expertise. Bringing along a broad network, we help you to successfully develop your product into the clinical phase. With our proven pick-and-choose concept we provide you clinical product development compliant with the latest ISO and GMP standards.
Our specialists work together with you and your team in a fully equipped and state of the art biomedical co-working space – whenever it suits you. More about Medace.
