Olivier Roy
Qualification and EMC in Medical Devices
"Almost every device fails its first EMC campaign."
Olivier Roy is the Head of Cicor’s EMC Lab in Angers, France, where he and his team of experienced engineers specialise in electromagnetic compatibility (EMC) and radio testing for medical devices and other electronic products. We spoke with him about why qualification is a crucial stage in MedTech development, the common pitfalls companies face, and how Cicor’s integrated approach helps customers avoid delays and costly redesigns.
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Qualification and EMC in Medical Devices – Olivier Roy’s Full Interview
Olivier, why is qualification such an important step in medical device development?
Qualification is mandatory for any electronic medical device before it can be placed on the market. It ensures the product meets all applicable regulatory requirements and can operate safely in its intended environment. In MedTech, this often includes compliance with standards such as EN 60601-1-2 for electromagnetic compatibility and related radio performance regulations. I expect qualification to become even more demanding as devices integrate more wireless features and AI processing.
For our customers, qualification is more than a legal formality but it is a way to identify potential issues early and correct them before large investments in production are made. A device that passes qualification can move straight into manufacturing, while one that fails can face months of redesign and retesting. That is why we encourage customers to think about EMC and radio requirements from the earliest design stages.
"Early EMC analysis saves time and cost."
What challenges do MedTech companies typically face when it comes to EMC and radio testing?
One of the biggest challenges is that almost every product fails at least one aspect of its first EMC test campaign. This is not because the companies lack technical expertise, but because EMC and radio compliance have their own complex rules that are not always considered early enough in the design. For example, a change in PCB layout, shielding, or component choice can make the difference between passing and failing a test.
Another common issue is underestimating how long the qualification process can take. If a product fails late in the project, redesign and retesting can cause serious delays to market launch. This is why early EMC risk analysis and targeted pre-tests are so valuable, as they allow customers to identify and fix potential problems before entering the formal qualification campaign.
How does your EMC Lab support customers in overcoming these challenges?
Our approach is to work closely with customers from the earliest stages of development. Because the EMC Lab is part of Cicor, we can collaborate directly with our R&D teams and the customer’s own engineers to make sure the design is prepared for testing. This can include reviewing schematics, advising on PCB layout, and suggesting component changes that will improve EMC performance.
We also run pre-tests in our COFRAC-accredited lab, which means results are recognised by notified bodies. Our flexible scope allows us to adapt quickly if a new standard or requirement appears during the project. And because Cicor combines development, qualification, and manufacturing, we ensure that any design changes made for EMC compliance are compatible with large-scale production, saving both time and cost.
"Being part of Cicor means we can test, advise, and adapt designs with manufacturing in mind."
What is the advantage of working with Cicor for qualification?
The key difference is that we are part of a complete development and manufacturing organisation. This means our work in the EMC Lab is fully integrated with the engineering and production process. When a customer comes to us for qualification, they are not only getting accredited testing but also the ability to make design changes quickly.
Independent test labs can identify a problem, but they rarely help redesign the product in a way that fits both compliance and manufacturing requirements. At Cicor, we bridge that gap. Our engineers can suggest practical, production-ready solutions, which helps customers get their products to market faster and with less risk.
What do you like about working in qualification?
I generally like to find solutions to complex problems. My team and I, in some ways, feel a bit like being “ghostbusters”, but with spectrum analysers. It's interesting and rewarding to track down invisible issues that can interfere with a device and making sure they are gone before it reaches the market.
About Olivier
Olivier Roy is the Head of Cicor’s EMC Lab in Angers, France, where he and his team of experienced engineers specialise in electromagnetic compatibility (EMC) and radio testing for medical devices and other electronic products. With almost three decades of experience in electronics and compliance, Olivier works closely with customers to ensure their products meet strict regulatory requirements, pass EMC and radio tests, and are ready for market launch.
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Let’s talk about your next MedTech project
Whether you’re developing a new device or scaling up for production, Cicor’s experts are here to support you every step of the way. With our integrated engineering and manufacturing capabilities, we help you bring innovative products to market faster and with fewer risks. Get in touch with us today to start the conversation. We’ll get back to you within 3 business days.