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...
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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...
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...
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...
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 further reinforced its knowhow in medical device design and development. Linda Kellberg (M.Sc., Tech.), Manu Sutela (SW Engineer) and Matti Nikkari (Senior Engineer, Electronics)...
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 ready...
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, building...
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 from...
