Unitron live at FHI 2024

Innovation in an existing medical device – the impact of changes on development, manufacturing and regulatory processes

Unitron live at FHI-Medical Electronics event in Vianen

On the 6th of February, Unitron Group is presenting a session during the Medical Electronics event (FHI).

Nico Zeeders (Unitron Regulatory manager) and Maria Dullaert (R&D Engineering Project Leader) will present the following session: “Innovation in an existing medical device – the impact of changes on development, manufacturing and regulatory processes”.  Before, during and after the session, Unitron Group can be found at booth number 20.

A short summary of the presentation is available to read below:

‘Once certified and on the market, the opportunities to change a medical device become very limited. Design and documentation have been approved by regulatory authorities, manufacturing processes and supply chains have been established, and budget and resources are allocated to other activities. Still, sometimes a product change is necessary, desired, or inevitable.

We are a development, contract manufacturing and regulatory support partner for medical and life-science equipment. In this session, we will take one of our in-house developed medical devices as an example. We will elaborate on the impact of a seemingly simple change to the defined use of the product, to its design, its manufacturing processes, and its documentation. We will discuss the importance of product scope and product iterations: to know and define what, when, where and why you should launch your product in the most efficient way.’

Interested in joining Unitron at FHI? You can sign up by clicking on this link.