Why having a second supplier could make sense even if it costs more.
Having dual sourcing of important components causes additional work, takes more time and ...
Author Aurevia:
IVDR Application Process – What do you need to know?
QAdvis have invited Charlotte Hess from BSI to give us some “need-to-know” when you plan for your ...
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 ...