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,...
Recent Posts
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...
D-fend Pro Water Traps are designed to protect patient monitors from moisture, humidity and contaminants. Innokas Medical is GE Healthcare’s contract manufacturing partner, producing the product...
“At Innokas Medical, everything begins with the quality built into our processes, products and services. The most important know-how as well as the high standards of our daily operation can be...
The FDA conducted an inspection at Innokas Medical’s Helsinki factory at the end of October during which it evaluated how Innokas follows FDA Quality Systems requirements (21 CFR part 820). Both...
Optomed Oy is a Finnish medical technology company that specializes in retinal imaging devices and solutions. Optomed was established in 2005. The company’s product portfolio consists of unique...
Innokas Medical and Icare Finland have recently signed a manufacturing agreement. The contract covers the manufacturing of Icare® HOME tonometer at Innokas Kempele factory. The actual work has...
The Carescape VC150 patient monitor, developed in cooperation between Innokas Medical and GE Healthcare, has reached a significant milestone as the monitor has been released for sale. In addition...
Guidance and counseling related to FDA audits are among the services that Innokas Medical has provided for its customers. Now Innokas Medical has created a separate product based on this know-how,...
The FDA conducted two inspections at Innokas Medical a few months apart. Both the inspector and Innokas Medical are satisfied with the results. Our processes are well planned and implemented in...
