Innokas Medical Business Blog

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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...

How to choose the right co-creation partner to save both time and money when designing and developing medical devices?

MedTech business is changing and getting more diverse. The technical complexity, caused mainly by digitization, is increasing. New technologies are being introduced at faster pace, the impact of...

How to shorten the medical device development cycle in practice?

MedTech business is changing and getting more diverse. The technical complexity, different forms of digitalization and related regulatory requirements are increasing as we speak. And there is 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,...

Innokas Medical has reinforced its know-how in medical device design and development: new employees have joined Innokas’ Design Studio team

Innokas Medical has further reinforced its knowhow in medical device design and development. Linda Kellberg (M.Sc., Tech.), Manu Sutela (SW Engineer) and Matti Nikkari (Senior Engineer,...

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...

A unique industry requires unique skills – medical device design and development in regulated world

Medical device industry is commonly characterized as regulated domain. Before introducing new medical devices to the market, there’s much more than simply coming up with an innovative idea,...

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...

Health Business Breakfast – How to co-create next generation medical devices in an agile way?

Innokas Medical, Olfactomics and BusinessOulu/OuluHealth are arranging Health Business Breakfast event in Oulu in the beginning of November. Welcome to listen, discuss and network with the...

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how to ensure the quality compliance of your medical product

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