Medical devices: urgent needs vs regulation
Here's what you'll learn
Understand the key changes of MDR
Derogations of the regulations in scope of COVID-19
Learn the full product lifecycle of Medical Devices
Part I: Medical devices lifecycle: urgent needs vs regulations
Covid-19 pandemic heavily affected the Medical Device industry. First and foremost, the implementation of the EU medical device regulations (2017/745) were postponed with year. Additionally, the European commission temporary allows derogation from the regulations in response to the outbreak.
Part II: Case Study: Autonomous robotic intradermal vaccination
With COVID-19 vaccines in development and being evaluated in clinical trials, ROB-ID, an automated intradermal delivery robot, aims to meet vaccine shortages, increase vaccination coverage, and trigger Dose Sparing effects.
Within a time frame of less than a minute, the autonomous system – developed with Voxdale – will administer a vaccine painlessly, while unloading healthcare professionals, with respect for physical distancing.
Vincent Van Fulpen
Project Manager Medical Devices at QbD
Founder of Voxdale and CTO of Novosanis