Last summer, Lybe Scientific got its first product registered as a CE-marked IVD medical device fulfilling the requirements set by In Vitro Diagnostic Directive (IVDD). The company built an ISO 13485...
Recent Posts
DC-Air™ is an intraoral x-ray imaging sensor designed, developed, and manufactured by a Finnish company Athlos. In July 2021, the sensor passed the FDA 510(k) clearance and is now legally permitted...
Long-awaited moment finally happened in May, as after a one-year delay the European Union's new Medical Device Regulation (MDR) came into force. We at Innokas Medical are well-prepared for the MDR...
Innokas Medical participated in the project where the regulatory framework for NTNU’s new set of reagents were created.
Medical device regulations include requirements with which both the device and their manufacturer need to comply to enable legal market entry. However, these requirements are often vaque, described...
Healthcare technology is one of the largest high-tech export segments of Finnish industry, and it continues to grow strongly year after year. In addition to growth, the industry is evolving with...
Through MDSAP (Medical Device Single Audit) certificate, the companies are able to indicate they operate according to ISO 13485:2016 -standard and regulatory requirements set by Australia, Brazil,...
WellO2, innovation developed by the Finnish company WellO2 Oy (formerly known as Hapella Oy), is a breathing exercise device that strengthens and cleanses the lungs. The mission of the company is to...
