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.
Nico Zeeders & Maria Dullaert, Unitron Regulatory
Klik hier voor de PDF-versie van de presentatie