Unitron Live at FHI Leusden

Regulatory in product development, the golden expertise. Avoid going back to the drawing board.

Live at FHI-Medical Electronics event

On February 7, Unitron Group will give a presentation at the Medische Elektronica; Ontwikkelingen, normen en toepassingen event of the Federatie and Technologiebranches (FHI).

Besides this, you can find Unitron Group in the Expo during the day at the following location: stand 11. Nico Zeeders, team leader Unitron Regulatory, and Maria Dullaert, Project Lead R&D Engineering, will provide the following session: ‘‘Regulatory in product development, the golden expertise. Avoid going back to the drawing board.’’  Please find the abstract of the session below.

You are a start-up entrepreneur, looking for the quickest way to get your innovation to the market. Or, you are a large corporate organization, wanting to expand your portfolio with an improved variant of one of your existing products. You are ready to enter production stage and to finally make some revenue out of your development investments. Then, you find that you have hard times getting past regulatory approvals for the intended markets: the test labs, Notified Bodies, or authorities are unable to readily understand how your design came to be, why it is safe to use, or how it was validated.

We are a medical product development and contract manufacturing partner, with specific regulatory support expertise. In this session, we will take one of our in-house developed medical devices, a surgical single-use electronic tool, that is currently entering production stage. We will show how regulatory aspects like electrical safety, thermal management, EMC, biocompatibility, packaging and sterilization impacted design and manufacturing choices, and why it is important to address these topics from the earliest development stages. We will discuss the importance of scope and focus: to know and define what, when, where and why you would want to develop and launch your product.

At this moment, the session is  fully booked.

The focus of the Medical Electronica Event is on the development, regulation and production of medical electronics and other applications. Current topics in this area are (among other things): the growing demand for wearables and the increase in self-control and monitoring. You can find more information about the program at the event website: Medische Elektronica – Ontwikkelingen en toepassingen (fhi.nl)