Eliane Masih on how Unitron supports customers with certification and compliance

Regulatory involvement from the very first idea

Eliane has been working at Unitron for a year and joined the Unitron Regulatory Department in Hengelo almost immediately after completing her degree in Biomedical Engineering. “Many of my fellow students focused primarily on the development of medical devices. I, on the other hand, discovered that my interest lay in the laws and regulations involved in that process. You can design and test something great, but ultimately it also has to meet all the requirements and standards. I found that just as interesting.”

Through a networking event at the University of Twente, she came into contact with employees from Unitron’s Regulatory Department. It was precisely because Unitron explicitly highlighted its own Regulatory Department during the event that the company immediately caught her attention. “At Unitron, I saw that it was truly an important discipline within the organization. That’s when the decision was made quickly.”

Regulatory oversees the entire development process

Regulatory plays a role throughout the entire lifecycle of a medical device. Sometimes Eliane and her colleagues are involved as soon as an initial idea is conceived; other times, they join an existing development process later on or work on medical devices that are already on the market.

“For example, clients come to Unitron asking which laws or standards a product must comply with. But we’re also involved during the development process itself. In those cases, we help review requirements, documentation, testing, and the interpretation of the results.”

According to Eliane, the role of regulatory affairs is sometimes underestimated in this context. “Sometimes clients think it’s just a document you have to put together. But it’s much more than that. You have to think things through carefully, execute them properly, and document them correctly.”

That’s why, in her view, regulatory doesn’t lag behind the development process—it runs parallel to it. “That’s why you build up the documentation throughout the entire development process, not just at the end. Think of development files, requirements, and their verification and validation. If those aren’t properly documented, it can significantly delay the market launch.”

Customized support for every customer

The work of the Regulatory Department varies greatly from client to client. Some organizations have their own Quality & Regulatory team and primarily need specialized advice. Other clients do not have that expertise in-house. In both cases, Unitron can add significant value.

“In the latter case, we provide more intensive and long-term support. For example, we assist with technical documentation, quality management systems, audits, and other tasks related to the role of legal manufacturer.”

According to Eliane, it’s precisely this variety that makes the work interesting. “With every client, you take on a different role. Sometimes you’re primarily a consultant; other times, you actually take on tasks that would normally fall under an in-house Quality & Regulatory department.”

She regularly notices that clients appreciate this support. “We often hear that clients are happy that we think of things they hadn’t considered themselves. Or that they simply didn’t know what was involved, especially now that regulations are becoming increasingly complex.”

Regulatory as an essential part of the development team

Developing a medical device requires more than just technical knowledge. That is why the specialists in Unitron’s Regulatory and Research & Development (R&D) departments work closely together from the very start of a project. This ensures that technical decisions are immediately evaluated against applicable laws and regulations, helping to prevent problems later in the development process.

“Our departments are right next to each other. That makes it easy to pop in, and we can respond quickly. For example, sometimes colleagues from R&D ask for help with a risk analysis or documentation. Conversely, we ask for information needed for technical documentation or compliance.”

According to Eliane, that is precisely where the strength of the collaboration lies. “Together, we ensure that a product not only works technically but also ultimately complies with all regulations. This allows it to obtain the necessary approval to be brought to market and remain there.”

Support for certification audits

For many organizations, a certification audit like this is a nerve-wracking and intensive phase, both leading up to market launch and later in the life cycle of a medical device. That’s precisely when Unitron’s expertise makes all the difference. Eliane looks back with pride on a project in which the Regulatory Department guided the client. “On behalf of a client, we chaired a certification audit conducted by an external certification body, and it yielded excellent results. The client was very satisfied with the final outcome.”

“During an audit, the quality management system (QMS), the technical documentation, and the underlying processes are really put under the microscope. It’s great when you can support a client and ensure they can count on a positive outcome.”

A field that continues to grow

The demand for regulatory support is on the rise. According to Eliane, this is mainly because the laws and regulations governing medical devices are becoming increasingly comprehensive. Consider, for example, the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), the European legislation governing the safety of medical devices.

“You notice that more and more requirements are being added—not only from the MDR, but also in other areas, such as the new European laws on batteries and packaging. As a result, you have to stay constantly up to date on new developments.”

She also sees this trend within Unitron. “Since I’ve been working here, I’ve noticed that the demand for regulatory support is increasing. Our department is growing along with it and is being involved in projects more and more often.”
According to Eliane, this is a logical development. “Regulatory matters are increasingly getting the attention they deserve. We actively participate in the development process and help customers make the right choices. This helps prevent problems later on in the process.”

For Eliane, that may well be the most important lesson: the earlier regulatory considerations are integrated into a development process, the stronger the foundation for a smooth and successful market launch.