The Danish 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 QA and Clinical Trial team. 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.
“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,” said RSP System’s CEO, Andreas Jenne.
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, reports the company.