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How to build and deploy an efficient QMS with speed – case Lybe Scientific

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...

Innokas Medical helped Athlos get FDA clearance for its Bluetooth®, direct conversion intraoral sensor

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...

MDR is here!

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...

NTNU Technology Transfer relies on Innokas’ strong expertise in quality and regulatory management

Innokas Medical participated in the project where the regulatory framework for NTNU’s new set of reagents were created.

Standard Compliance – a Must or a Myth?

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...

Innokas Medical develops data-driven solutions and software for regulated medical devices together with its customers

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...

Innokas Medical develops and manufactures medical devices for global market areas also in future

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 makes breathing easier

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...

EU funding helps companies to establish valuable international networks

Original source: Business Finland

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