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...
Recent Posts
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 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...
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...
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...
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...
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...
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...
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...