RSP Systems — non-invasive diagnostics company — has received the ISO 13485:2016 certificate, which is an important milestone towards its CE marking and product launch of its non-invasive glucose meter for diabetes management.
ISO certification
The company’s programme for the implementation of its Quality Management System started back in 2016 and is aimed at yielding MDR compliance and European market approval in 2020 for its glucose meter for diabetes management.
“This is the first tangible result from a focused process, starting with putting a great team together, dedicating resources and now demonstrating the ability of the team to deliver,” stated RSP System’s CEO, Andreas Jenne. “This bodes well for the overall success of our regulatory programme.”
The certification follows from the company’s latest financing round (Series B), which has provided an additional €6.5 million of funding towards more in depth clinical trials, CE marking, and preparations for market launch.