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Branching out – ISO 13485 beyond medical sector

What does certification tell you about a manufacturer? Many sectors in the field of technology have their own specific certificates that validate their expertise on the type of products they...

Ramp-up as a specialty – The benefits of an experienced manufacturing partner in Europe

Whether there is a design of electromechanical device that is still in its working phases or a product that already has a history of being produced at another location, ramp-up can be a challenging...

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...

How to build and deploy an efficient QMS with speed – case Lybe Scientific

Last summer, Lybe Scientific got its first product registered as a CE-marked IVD medical device fulfilling the requirements set by In Vitro Diagnostic Directive (IVDD). The company built an ISO 13485...

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,...

New manufacturing business in Innokas’ Kempele factory: the series production of Monidrop Infusion Therapy device has been started

The cooperation between Innokas Medical and Monidor Ltd. has developed to the next level during this year. The first steps of the cooperation were took already in 2015 when Innokas was offering QA...

At Innokas Medical, the quality is built into daily work and operation

“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 seen...

Optomed rely on Innokas’ strong expertise in quality and regulatory affairs

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...

SGS Fimko conducted several audits at Innokas in 2014

SGS Fimko has conducted several audits at Innokas Medical in 2014. The most significant audits were a follow-up audit of the ISO9001 and ISO13485 quality system certificates, a USTC audit, and a...

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