Here is a recipe on how to push through the MDR process in the shortest possible time. Based on my recent panel presentation at the MedFIT 2024, I have put together some key tips and ideas on what to...
Recent Posts
As of right now, the changes brought on by MDR have quickly heightened the need for clinical evaluation in the medical technology field. During the directive, the approach to clinical evaluation was...
Do you think of quality management as only one part of the progress of bringing your software device to the market? Preferably one that can be checked out as a last step before your software device...
Innokas Medical is present at the Health Valley Event (HVE) that will take place on March 30 with the theme of affordable and accessible healthcare supported by technological innovations. Make sure...
Manufacturers who have devices CE Marked to the directives MDD, AIMDD or IVDD (i.e., legacy devices) have deadlines for regulatory compliance if they want to keep their devices on the European...
The new MDR regulation has expanded the need for clinical evaluation in companies designing medical devices. The interview for my master's thesis highlighted the requirements set by the new...
Innokas Medical strengthens its QA&RA services with a new Clinical Affairs team. The new team supports medical device companies in carrying out resource-binding clinical evaluation related work by...
Ever since the European Commission published the new regulations for medical and in-vitro diagnostic devices, there have been serious concerns regarding the availability of medical devices and how...
Innokas Medical launched a service called MDR Fast Track earlier this year. The service enables MedTech companies to enter markets faster with reasonable effort and acceptable risk by outsourcing the...
