Pacertool passed Stage 1 of the ISO certification
Safety and quality are fundamental in the medical device industry and are strictly regulated by national and international authorities. This applies not only to all the phases of the product development, but also to the service, delivery, and all processes within the company. A quality management system of a medical device company must demonstrate best practice in everything it does.
The Pacertool team has worked hard to implement, from day one, a quality management system, that both complies with regulatory requirements and is practical to use daily, without being cumbersome. "Our QMS should be strict, but work for us and not we work for it", said CEO Hans Henrik Odland on the first days of Pacertool.
Pacertool have, on December 9, 2020, successfully passed the Stage 1 audit of ISO 13485:2016 with British Standards Institution (BSI), which confirms the readiness and relevance of the QMS implementation. This achievement sums up the hard work and ticks off an important milestone towards bringing the PaCRTool system to market. The Stage 2 audit is scheduled for March 2021.
The ISO certification will allow for initiating clinical investigations and pave the way for Pacertool to obtain market clearance for its products throughout the world, starting in Europe and the US.