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 ...
Extension of the MDR transitional period and removal of the “sell off” periods
European commission has now official published the Q&A on practical aspects related to the ...
Come and Meet Us at the Regulatory Summit on March 30th
We are present at Swedish Medtech’s Regulatory Summit on March 30th. Meet us here if you want to ...