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...
Recent Posts
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...
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,...
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...
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...
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,...
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...
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...
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)...
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...
