FDA released a draft guidance: Computer Software Assurance for Production and Quality System Software. What changes could it bring?
The Ministry of Health of Israel has just been included in the Medical Device Single Audit Program (MDSAP), what are the changes?
The US Breakthrough Device Designation Program can help your company speeding up your Medical Devices development, assessment and review.
MDUFA V is the latest amendment to the to the MDUFA Act, and it could bring an exceptional growth to the MD Community in the US.
Stephen Tyrpak, Executive Consultant @ PQE Group speaks about how to raise funds for your start up in the Life Science Industry.
The new Regulation 2017/746 for In Vitro Diagnostic medical devices has been published and the new requirements for Clinical Evidence are some of.
In our video, we review the most important requirements a MD company has to fulfill to achieve Compliance and ensure safety for its Medical Devices.
Understand the reasons why nowadays Cybersecurity has become a main concern for all Medical Devices producers.