Medical devices: urgent needs vs regulation


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.

Why would you join?

  • Understand the key changes of MDR

  • Derogations of the regulations in scope of COVID-19

  • Learn about early verification in a stringent design control process to decrease Time to Market and master the full product lifecycle of medical devices, not the least in pandemics like COVID-19.​​​​​​​ ​​​​​​​

  • Vincent Van Fulpen

    Project Manager Medical Devices at QbD

  • Koen Beyers

    Founder of Voxdale and CTO of Novosanis

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