Innokas Medical Business Blog

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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 software as a medical device under the new MDR in EU? Tips available!

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...

Conformity assessment and CE marking - are you ready for the new MDR with your existing products?

In our previous MDR related blog post we discussed how to proceed in implementing the new MDR to your Quality Management System. The QMS requirements are assessed for all existing certifications...

Prepare your QMS to the new MDR – tips available!

The new Medical Device Regulations (2017/745/EU) (MDR) will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC)...

Ready or not - the new European Medical Device Regulations (MDR) are coming!

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...

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how to ensure the quality compliance of your medical product

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