Professional Quality and Regulatory Services guiding You to master Your Medical Device compliance journey!
Do you feel there's tons of process guidance out there but you don't understand which...
Recent Posts
Innokas Medical has been invited to Health Tuesday -event organized by Business Finland, to tell our story how we have implemented the essential European regulatory requirements. Welcome to...
SoteDigi, who develops new kinds of digital solutions for patient- and health care, selected partner companies for further development of its Omaolo.fi -service solution in the beginning of this...
Many medical device design or manufacturing companies may find it difficult to allocate enough time and resources to master the regulatory compliance of medical device, and to compile, maintain,...
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...
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,...
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...
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...
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)...
