Innokas Medical Business Blog

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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...

Innokas Medical's top 10 blog posts of 2018!

New year and new beginnings – but first it’s time for 2018 year-end list! We took a look at which blog posts on Innokas Medical’s Business Blog were the most popular ones; so here are our top 10...

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,...

Save your time and money when designing and developing medical devices: choose a partner with substantial added value and more concrete benefits

MedTech as a business is changing and getting more diverse. For example, the technical complexity, forms of digitalization and regulatory requirements are something that are increasing as we...

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...

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...

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

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