September 26th 2023
The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use.
Combination Drug-Device Regulation in Malaysia, South Korea and Australia
April 12th 2023Representatives from regulatory authorities of the countries of Malaysia, Australia and South Korea discussed their respective challenges in the “International Drug-Device Combinations Session” at DIA Europe 2023.
Turning Challenges into Opportunities: Evaluation of Digital Health Products
August 4th 2022Shiri Diskin, PhD, Head of Medical Writing at Bioforum, sits down with Daphna Laifenfeld, PhD, Chief Scientific Officer at Ibex Medical Analytics to discuss the challenges associated with developing a CER and how to effectively navigate them while creating opportunities that increase efficiencies.