Unitron live bij FHI 2024

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

Unitron live bij FHI, het Medische Elektronica event in Vianen

Op 6 februari geeft Unitron Group een presentatie op het Medische Elektronica event; Ontwikkelingen, normen en toepassingen, georganiseerd door de Federatie van Technologiebranches (FHI).

Daarnaast kunt u Unitron Group gedurende de dag op de beurs bezoeken op stand nummer 20. Nico Zeeders, teamleider Unitron Regulatory en Maria Dullaert, projectleider R&D Engineering zullen de sessie: “Innovation in an existing medical device – the impact of changes on development, manufacturing and regulatory processes” presenteren. Lees alvast een korte samenvatting van de presentatie hieronder.

‘Once certified and on the market, the opportunities to change a medical device become very limited. Design and documentation has 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.’

Wilt u onze sessie graag bijwonen? Meld u aan door te klikken op deze link.