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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,...

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...

EU funding helps companies to establish valuable international networks

Original source: Business Finland

Co-creation across national boundaries – Innokas Medical supports Augere Medical to develop system for AI-driven analysis for colorectal cancer detection

Norwegian healthtech innovator Augere Medical AS has selected Innokas Medical as their co-creation partner to offer quality and regulatory as well as design and development support to bring their...

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how to ensure the quality compliance of your medical product