Latest Insights

Medical Device

FDA Software Guidance; Should I be worried?

FDA released a draft guidance: Computer Software Assurance for Production and Quality System Software. What changes could it bring?

Medical Device

Israel MDSAP Affiliate Membership

The Ministry of Health of Israel has just been included in the Medical Device Single Audit Program (MDSAP), what are the changes?

Medical Device

FDA’s Breakthrough Device Designation, Expediting Your Pathway to Market

The US Breakthrough Device Designation Program can help your company speeding up your Medical Devices development, assessment and review.

Medical Device

How could the Medical Device User Fee Amendment V Impact your MD company?

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.

Medical Device

Raising Funds for Your Start-Up

Stephen Tyrpak, Executive Consultant @ PQE Group speaks about how to raise funds for your start up in the Life Science Industry.

Medical Device

EU IVDR – Clinical Evidence and Performance Evaluation

The new Regulation 2017/746 for In Vitro Diagnostic medical devices has been published and the new requirements for Clinical Evidence are some of.

Medical Device

EU MDR 2017-745: New Cybersecurity Requirements for Networked MD producers

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.

Medical Device

Why MD Cybersecurity is so important

Understand the reasons why nowadays Cybersecurity has become a main concern for all Medical Devices producers.