Original Publication Use of Real-World Evidence for International Regulatory Decision Making in Medical Devices February 8, 2023 Read more
Original Publication Digital Health Technologies for Medical Devices – Real World Evidence Collection – Challenges and Solutions Towards Clinical Evidence August 26, 2022 Read more
Original Publication Preference Testing in Medical Devices: Current Framework and Regulatory Gaps July 6, 2022 Read more
Original Publication Post-Market Clinical Follow-up under Regulation (EU) 2017/745 on medical devices: Regulatory and statistical considerations March 7, 2022 Read more
Original Publication Common regulatory gaps in Clinical Evaluation Reports for medical devices and the pathway towards EU MDR transition December 5, 2021 Read more
Original Publication Companion Diagnostics: State of the Art and New Regulations October 12, 2021 Read more
Podcast Beyond an Immune Response – A Two Part Podcast Series. Episode 1 – The Wave March 5, 2021 Read more
Whitepaper Whitepaper: The in-vitro diagnostics Regulation (IVDR): Unravelling the challenges of the transition January 20, 2021 Read more
Whitepaper Whitepaper: State of the Art in the context of the new Medical Device Regulations January 20, 2021 Read more
Whitepaper Whitepaper: The in-vitro diagnostics Regulation (IVDR): Unravelling the challenges of the transition October 30, 2020 Read more
Original Publication Organ Donation in the US & Europe: The Supply vs Demand Imbalance October 22, 2020 Read more
Original Publication Backlog to Surgery due to COVID-19 and Considerations to Address to Catch-up Safely October 22, 2020 Read more
