Innokas Medical Business Blog

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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...

Competitiveness can be built by improving quality and regulatory management in medical device design and development

Before introducing new medical devices to the market, there’s much more than simply coming up with an innovative idea, building it, and offering it to the masses. One clear rule in the medical...

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...

FDA rules and regulations - tips for medical device companies for US market entry

To be able to enter the certain markets with a medical device, it is not enough to have just a good end-product - the development and production processes also have to fulfill certain criteria....

Ensure the quality compliance of your medical device – learn about the regulatory process in practice

Do you have an idea of a medical device? Or have you already started to develop your medical device? Do you want to enter, e.g., EU or US markets?

FAQs about quality compliance and regulatory affairs in medical business

Finding answers? Welcome! - This is an unofficial guidance which is intended to assist medical device OEMs by answering to some common and basic questions concerning quality compliance and...

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Design Thinking, Lean Start-Up and Agile Approaches in Medical Device Design and Development

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