What standards and regulations won't tell you, but veterans will.
In the land of Medical Devices, regulation is king, but risk management rules all. We welcome you to the next MedTech Community event to learn how to tame this beast from those who went before you. This is not an introduction; it's insight from beyond the finish line(s).
Date: June 10, 2026
Time: 13.00 - 16.00
Risk management is more than a checklist for compliance; it is a strategic discipline that can shape the success or failure of a medical device.
In this MedTech Community Event we move beyond the standards to focus on how risk management actually plays out in practice: what commonly goes wrong, which decisions truly make a difference, and how to integrate risk thinking across the full product life-cycle.
You will hear from four practitioners who have lived through it:
- Jean Blom (Medace) opens with the consequences of bad risk management and the must-take first steps at the concept stage;
- Ronald de Lange brings life-cycle risk management to life with practical examples: design changes, complaints, post-market surveillance, and clinical evaluation;
- in the panel, Victor Suturin (Aliform) and Dominik Klump (VACIS B.V.) widen the conversation across class I devices and devices that cannot claim a direct clinical benefit, moderated by Jean Blom.
What to expect
- Practical insights into risk management as a continuous, life-cycle discipline. Not just a compliance checklist
- Real-life experiences from concept stage through design changes, post-market surveillance and clinical evaluation
- Lessons learned, common pitfalls and best practices from MedTech veterans across different device classes and risk profiles
- Open conversation and networking with peers from the wider MedTech ecosystem
Who should attend?
This event is relevant for:
- Quality & Regulatory Affairs professionals in medical device companies
- MedTech innovators and product developers/leads, Founders, R&D Engineers, project managers, and CTOs
- Start-ups, scale-ups, and established MedTech companies
- Anyone navigating ISO 14971 and risk management in MedTech development
Programma
| Time | Title |
| 13.00 | Registration |
| 13.30 | Welcome & Opening |
| 13.45 | Risk Management 101: Why it matters in MedTech development by Jean Blom (Medace) The consequences of bad risk management and how to do better. Jean unpacks how ISO 14971 is a map that offers several valid routes, and the must-take first steps at the concept stage to set successful risk management up from day one. |
| 14.15 | From Concept to Compliant Product: Executing Risk Management well by Ronald de Lange Risk management as a continuous process throughout the full product life-cycle, including design decisions, design changes, complaint handling, post-market surveillance, and clinical evaluation. |
| 15.00 | Coffee break |
| 15.15 | Panel discussion: Voices from the Field with Victor Suturin (Aliform), Ronald de Lange, Dominik Klump (VACIS B.V.) & Jean Blom Innovators and experts discuss risk management pittfalls and dealing with setbacks, as well as which best practices come first (and which can wait). |
| 16.00 | Networking opportunity |
Presentaties
Risk Management 101: Why it matters in MedTech development
Jean will open by speaking on the consequences of bad risk management - both for the patients and users, but also for the company and regulatory landscape. He will then clarify varying paths that can be taken for executing risk management, and close with what you should have done at the start in terms of managing your own company and product's risk in this regard.
From Concept to Compliant Product: Executing Risk Management well
In Ronald's presentation he will touch upon medical device risk management as a life-cycle process. Using practical examples, Ronald will share insights in established risk management principles and best practices. This will include discussions on risk management during design changes, and how complaints, post-market surveillance and clinical evaluation can be used to support risk management.
Source: Brightlands