Robin StephensMar 53 min UK’s MHRA webinar on the new regulatory framework: 05 March 2024This morning (05 March 2024) the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) presented the first in a series of...
Jacques du PreezFeb 123 minFDA Final Rule: Medical Device Quality System Regulation AmendmentsBy Jacques du Preez & Mark Wiesner Feb 2024 For many years the rest of the world has been utilising the ISO 13485 Medical Device Quality...
Irfan HassanJan 151 minDigital Technology Assessment Criteria (DTAC)You can’t sell or pilot digital health technologies in the UK NHS and Social Care without DTAC and Clinical Safety compliance! The...
PsephosDec 13, 20231 minPractical Risk Management WorkshopOn 31st January 2024, we will be co-hosting a workshop called “Practical Risk Management for Software Devices” alongside UCL and...