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.
Nico Zeeders & Maria Dullaert, Unitron Regulatory