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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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...
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...
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 field...
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) (AIMDD)....
