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Now in its 17th year, FDAnews’ Medical Device Quality Congress (MDQC) is the must-attend annual quality and compliance event for devicemakers.

Come network and receive the latest insights directly from current and former FDA officials and industry leaders from the world’s major markets.

This is the opportunity for medical device quality and regulatory professionals to discover the latest trends and master the processes they must perfect. The sessions will cover US and international critical topics to ensure you are ready to market globally:

  • FDA’s 2020 medical device regulation agenda and Center for Devices and Radiological Health’s (CDRH) priorities
  • Implementation of the clinical evaluation or performance evaluation process
  • Impact of new economic operators in the EU Medical Device Regulation (EU-MDR) and EU In Vitro Diagnostics Regulation (EU-IVDR)
  • QMS under EU-MDR and EU-IVDR
  • Complaint reporting — US medical device reporting (MDR) and EU manufacturer’s incident report (MIR)
  • Corrective actions — US and EU perspectives
  • Risk management systems (RMS) under ISO 14971:2019
  • Postmarket surveillance (PMS) in EU-MDR/IVDR
  • Mock trial: the product liability lawsuit


Get the latest in regulations, process changes and invaluable shared device experiences direct from those on the front lines at the Medical Device Quality Congress.

Add on the day-long Post-Conference Training to ensure you remain compliant with up-to-the-minute data analysis methods and statistical techniques. Get exact guidance on how to make your Quality Management System (QMS) work to your best advantage.

Full Agendas: Day 1, Day 2 and Post-Conference Training

Chat with high-level agency officials sharing regulatory secrets… top-flight FDA-centric lawyers spouting legal advice… private-sector experts who’ll illuminate your path forward… sought-after consultants sharing their vast technical expertise. You can’t afford to miss this conference.         

This year’s MDQC is at the light-filled Bethesdan Hotel in Bethesda, MD, situated halfway between FDA headquarters and the nation’s capital. Mid- to late-April is an ideal time to enjoy the area’s gentle breezes and spring flowers. Or take in Washington, D.C.’s array of cultural offerings either before or after the multi-day events.

Mark your calendar for April 20-22. You can’t afford to miss 2020’s most important event for devicemakers, the 17th Annual Medical Device Quality Congress.