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...
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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, 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...
The design and manufacturing of medical devices is way more challenging than engineering work and factory production of e.g. consumer electronics. In medical device business, it is not enough to...
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...
Professional Quality and Regulatory Services guiding You to master Your Medical Device compliance journey!
Do you feel there's tons of process guidance out there but you don't understand which...
SoteDigi, who develops new kinds of digital solutions for patient- and health care, selected partner companies for further development of its Omaolo.fi -service solution in the beginning of this...
Many medical device design or manufacturing companies may find it difficult to allocate enough time and resources to master the regulatory compliance of medical device, and to compile, maintain,...
When creating a new medical device to the market, there’s much more that goes into designing, developing and introducing it to the market. To be able to enter the certain markets, the development...