RSP Systems is Awarded the ISO 13485:2016 Certification from LRQA, an Important Milestone Towards CE Marking and Product Launch
Odense, Denmark, August 07, 2018 / B3C newswire / -- RSP Systems A/S, the non-invasive diagnostics company, announces that it has received the ISO 13485:2016 certificate, demonstrating commitment to placing its non-invasive glucose meter for diabetes management on the market.
The process of implementing RSP System’s Quality Management System began in late 2016 with the building of a strong QA and Clinical Trial team. This effort has gradually strengthened, and the newly awarded certification is the achievement of the first important milestone for the program, which has the overall aim of yielding MDR compliance and European market approval in 2020 for RSP System’s glucose meter for diabetes management.
RSP System’s CEO, Andreas Jenne, added: ‘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. This bodes well for the overall success of our regulatory program.’
The ISO 13485 Certification follows on the heels of the recent Series B financing round, which to date has provided an additional €6.5 million of funding towards more in depth clinical trials, CE marking, and preparations for market launch.
About RSP Systems A/S
RSP Systems is a Danish biotechnology company founded in 2006 as a spinout from Odense University focused on using Raman spectroscopy for human diagnostics. Raman is a well-understood and widely applied technology, but its employment for human diagnostics has long eluded industry. RSP Systems has now taken the hurdles and offers the world’s first robust diagnostic system. Over the past 6 years, the company has aimed for glucose and has now developed a prototype which shows target performance in clinical studies on diabetic patients at the University of Odense. The company is now integrating its technology into a consumer device as the first non-invasive glucose monitor of analytical quality for diabetic patients. Other applications will follow the market launch.
Anders Weber, CSO