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Specialist’s insight – Is there a way for rapid market entry for medical devices?

Innokas Medical launched a service called MDR Fast Track earlier this year. The service enables MedTech companies to enter markets faster with reasonable effort and acceptable risk by outsourcing the...

HIMSS 2022 Europe – Three Days of Health, Care & Wellbeing

The hot topics in HIMSS (Healthcare Information and Management Systems Society) Europe exhibition in Helsinki were human centricity and how to enable easier connectivity and interoperability with...

Our new strategy shows in 2022 HIMSS in Helsinki June 14-16th

Last year Innokas launched a new strategy to seek strong growth. This means we are extending our presence into new market areas as well as developing our services and launching new ones. In 2022 we...

The MDR Fast Track service enables MedTech companies to reach the market faster by outsourcing the regulatory burden

Innokas Medical, a Finnish technology company specializing in medical technology, is launching an outsourced responsible manufacturer service for companies striving to reach the highly regulated...

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...

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