International conference focuses on regulations and standards for medical technology

AAMI, BSI and FDA collaborate at international forum

The Association for the Advancement of Medical Instrumentation (AAMI), the US Food and Drug Administration (FDA) and BSI are hosting an international conference on medical devices standards and regulation. The detailed programme has been released. The conference will be held in Reston, Virginia on 24-25 April 2019. The event brings together a variety of speakers from regulatory authorities, notified bodies, standards development organizations and industry. They will discuss a broad range of interrelated subjects. The programme provides an opportunity not only to get a high-level perspective but also to look in depth at issues of particular current relevance.

The programme includes two keynote presentations; one comparing safety perspectives in healthcare with the airline industry and the other providing a insight on future trends in regulations of medical devices from the UK MHRA. Other sessions include:

• FDA updates on
  • Safety and performance pathways
  • The Accreditation Scheme for Conformity Assessment (ASCA) of medical devices
  • The programme for the adoption of standards
  • Digital health initiatives
• Machine learning and artificial intelligence in medical technology
• Implementation of the European Medical Devices Regulations with a focus on:
  • Clinical evidence
  • Technical documentation
• Brexit
• Updates and practical experiences of  
  • International Medical Device Regulatory Forum (IMDRF)
  • The Medical Devices Single Audit Programme (MDSAP)
• Updates on standards and regulations for
  • Quality management systems for medical devices
  • Cybersecurity
  • Risk management
  • Medical device software
  • Post-market servicing, repair and refurbishment
  • Interoperability
  • Sterilization and packaging for sterile devices
  • Unique Device Identification (UDI)
  • Medical electrical equipment
  • Good clinical practice and biocompatibility

The conference is a unique opportunity to get the latest information on important regulatory developments. It links these developments to the international standards that are being prepared to support regulatory requirements.  As regulations and standards evolve, it is critical to keep up to date with the changes being introduced and how they are being interpreted. This is an opportunity to interact directly with the people intimately involved in work on these topics to hear the latest information and get your questions answered in focused workshop-style sessions.

BSI and AAMI are also collaborating to bring the International Conference on medical devices standards and regulation back to Europe in 2019. This will be held on 27-28 June 2019 in central London.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development