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Specialist’s insight – How to tackle the changes within the transition periods of regulations?

Manufacturers who have devices CE Marked to the directives MDD, AIMDD or IVDD (i.e., legacy devices) have deadlines for regulatory compliance if they want to keep their devices on the European...

The expansion of clinical evaluation has increased the need for clinical competence in companies designing medical devices

The new MDR regulation has expanded the need for clinical evaluation in companies designing medical devices. The interview for my master's thesis highlighted the requirements set by the new...

Innokas Medical addresses the growing need for clinical affairs services

Innokas Medical strengthens its QA&RA services with a new Clinical Affairs team. The new team supports medical device companies in carrying out resource-binding clinical evaluation related work by...

Specialist’s insight – What is the current availability of Notified Bodies?

Ever since the European Commission published the new regulations for medical and in-vitro diagnostic devices, there have been serious concerns regarding the availability of medical devices and how...

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...

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...

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