FDA issues a new version of ISO 10993-1 guidance, which impact devices with intact skin contact
In September 2023, FDA released a new version of their guidance “Use of International Standard ISO ...
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Medicinteknikdagarna 2023
Upplever du att de medicintekniska regelverken är lite krångliga och ibland svåra att navigera i, ...
Do you remember the FDA eSubmitter?
Over the years, the FDA has had several 510(k) submission programs to make the process more ...
Do you as a medical device manufacturer consider the intended environment of use when you design alarm sounds?
Based on experience in emergency/intensive care and equally within the medical device industry, we ...
Advancing clinical research together
Scandinavian CRO (SCRO) and Cardialysis are contract research organizations (CROs) in the field of ...
Whenever you see a successful business, someone once made a courageous decision.
The above is a quote from Peter Drucker (1909 – 2005) the founding father of modern management ...
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 ...
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 ...