Grundium, Finland based medical imaging device company, is pleased to announce that it has been certified to ISO 13485:2016 by leading Certification Body – Lloyd’s Register Quality Assurance, for the development, manufacturing, marketing and sales of digital microscopy products. This ISO certification indicates that the company’s quality management system meets the most current regulatory requirements specific to the medical device industry.
“Understanding and meeting customer requirements has been a core value to Grundium from the beginning. We are very proud of this certification. It demonstrates the commitment of our team to quality and proves that we can meet medical customer expectations and international regulatory requirements.” said Mika Kuisma, co-founder and CEO of Grundium.
“Developing our quality system to meet ISO 13485:2016 requirements has been valuable journey to our team. We have applied risk-based approach to commercialization of our unique technology, and are now ready to deliver high quality products to the global customers.” said Janne Haavisto, co-founder and CTO of Grundium.
Based in Tampere, Finland, Grundium is developing and manufacturing portable digital microscope scanners for medical professionals. The Grundium Ocus is a monumental leap in digital pathology. It is a precision tool small and affordable enough to be on every medical professional’s desk. It is truly portable and it can be brought anywhere. Wireless connectivity means telepathology is now possible practically anywhere on the planet. The Grundium Ocus is your personal microscope scanner to make daily work faster and easier.