Medical Device Expertise
Comprehensive medical device testing and complete standards compliance review is a process built over time. UL has the ability to use its decades of clinical and regulatory expertise to test to the medical device standards you see across the market, such as:
But what if your device falls outside of the norm? What if your product is completely unique and requires special attention?
A client had a need for some testing outside the certification scope. They were looking for the response time of their device as affected by extreme cold & hot temps. They contracted us to cycle their device between the extreme limits as we recorded the functionality of their product under these harsh conditions. The emergence of new technology is constant. As manufacturers and developers implement new tech into their products, it is important to be able to confidently test given the new parameters. In addition, when new tech is implemented, innovations are often attached. These new products and devices require engineers and facilities that can accommodate and understand the evolved complexities and purposes.
Our engineers stayed ahead of the curve with persistent training and updated facilities to accommodate this request. For the developer and manufacturer, this meant personal conversations that determined what was in the product, what its features were and what is the designed purpose. Once we had those items outlined we worked in lock-step with our client to design a customized, top-to-bottom solution for this specialized product. With facilities across the world and over 159 testing facilities, UL would be able to build a solution any client’s unique device.
While we are all working to innovate, the standards are also keeping pace. Our industry experts a always working to fully understand, and often author, standards and regulatory requirements for healthcare devices. When it comes to customized testing UL experts are versed in over 1,600 standards across global markets, including FDA (US), MFDS (Korean FDA), EU IVD, EU MDD. Visit our page to learn more.