Local representative and what you need to know
Several countries require an in-country representative. This company is often chosen by the ...
Finally, summer vacation!
During the late spring, the time for summer and for vacation can feel far away. But one thing is ...
Gardening – Just like a medical device registration, it needs to be maintained!
Everyone who has a garden knows that the work in the garden is never done. Even if you have done ...
Regulatory requirements are a design input.
What is the purpose of developing a medical device? If you ask your employees, the probable answer ...
Welcome to us Kecke Elmroth
With a solid background from Medical Affairs in MedTech industry and academic Life Science ...
Is UDI for medical devices as complicated as it seems?
Purpose of implementing a device identification system is to improve patient safety by making the ...
Clinical research – increasing hope for more patients
To keep up with the development of new pharmaceuticals and medical devices, more clinical studies ...
Thanks to Swedish Medtech Regulatory Summit
Last week we were present at the Swedish Medtech Regulatory Summit. A big thank you to Swedish ...
… with BSI regarding MDR-Application Process
MDR Application Process – What do you need to know? QAdvis have invited Magnus Olla from BSI in ...