Muna Kebede

Jun 20, 2024 | meddeviceonline.com | Leslie Hammermüller |Muna Kebede |Matthias Fink |Emily Thorpe

Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | June 20, 2024 The Medical Device Coordination Group (MDCG) published the new 2024-3 guidance document relating to clinical investigations of medical devices. How does it complement existing guidance and regulation?

May 30, 2024 | clinicalleader.com | Muna Kebede |Matthias Fink |Leslie Hammermüller

How Can We Improve Clinical Trial Feasibility Processes? Clinical Leader Live uncovers how experts work to overcome frustrations in the feasibility and site selection process for clinical trials. Hear from speakers from J&J Innovative Medicines, Takeda, and CSL Behring on ways they’ve been able to improve the feasibility assessment process. Reserve your spot today for this May 30th digital event. Registration is free thanks to the support of inSeption Group.

May 22, 2024 | meddeviceonline.com | Muna Kebede |Matthias Fink

By Leslie Hammerm├╝ller, Muna Kebede, and Matthias Fink The Regulation (EU) 2017/745 (EU MDR)1 requires a pre-market clinical investigation for implantable and Class III medical devices unless one of the exemptions in Articles 61(4), 61(5), and 61(6) applies. The more stringent approach to demonstrating equivalence, especially to a medical device manufactured by a competitor, will likely increase the number of pre-market clinical investigations for new implantable and Class III devices.

May 22, 2024 | clinicalleader.com | Muna Kebede |Matthias Fink

By Leslie Hammerm├╝ller, Muna Kebede, and Matthias Fink The Regulation (EU) 2017/745 (EU MDR)1 requires a pre-market clinical investigation for implantable and Class III medical devices unless one of the exemptions in Articles 61(4), 61(5), and 61(6) applies. The more stringent approach to demonstrating equivalence, especially to a medical device manufactured by a competitor, will likely increase the number of pre-market clinical investigations for new implantable and Class III devices.

Aug 25, 2023 | clinicalleader.com | Muna Kebede |Matthias Fink |OCT Clinical |IQVIA Biotech

Get more clinical research insight with our FREE newsletter Newsletter | August 25, 2023 Webinar: Look Before You Leap Legacy inclusion/exclusion criteria can hinder patient recruitment, suppress diversity, and derail clinical-trial timeframes.