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...
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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...
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...
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...
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....
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?
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...
