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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...

We help you to master your Medical Device compliance journey!

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...

Innokas Medical discusses about the new MDR in Health Tuesday -event

Innokas Medical has been invited to Health Tuesday -event organized by Business Finland, to tell our story how we have implemented the essential European regulatory requirements. Welcome to...

Innokas Medical was chosen as contract supplier with frame agreement on SoteDigi’s MDR consultation project

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...

Innokas Medical’s quality and regulatory services become more diversified

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,...

It’s only less than a year to the new European Medical Device Regulations (MDR) – are you ready?

Due to the changes in the medical device legislation in the EU, there’s a lot of things you need to know as a medical device manufacturer. That’s why we decided to start a blog post series in the...

Are you ready for stricter rules for SaMD under the new MDR in EU?

The new Medical Device Regulations (2017/745/EU) (MDR), published in May 2017, will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices...

Tips available! How to prepare to the new European Medical Device Regulations (MDR)?

Finding answers? Welcome! - This is an unofficial guidance which is intended to assist medical device OEMs by sharing some tips on how to prepare to the new European Medical Device Regulations,...

Conformity assessment and CE marking – get your new Medical Device to the market under new European Medical Device Regulation

In our previous MDR related blog post we discussed on how to ensure that your existing products are compliant with the new medical device regulation. Now we’re sharing some tips on how to get...

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