Healthcare is being revolutionized through the synergistic development of information technology and medical devices, and regulators are starting to realize that healthcare software cannot be ignored or adequately regulated by analogy to hardware alone. However, there is little consistency in the extent or content of new regulations being introduced.

This audio conference presentation is targeted at those involved in developing medical devices with software, or software to be used in a healthcare environment, who want a high-level overview of the regulatory landscape and a better understanding of current issues. Our speaker discusses the evolution of medical device software regulations, summarizing the current regulatory requirements in major markets. We also explore some forthcoming issues, and how current product development can be “future-proofed” against new regulations.

This audio conference covers:

• How software becomes a medical device
• Why medical software has to be regulated
• The different regulatory regimes in different jurisdictions
• The common features of different regulatory approaches
• Approaches to regulation of global trade and the Internet

About the speaker:

Neil R. Armstrong, BSc CEng MIET FTOPRA RAC FRAPS is principal consultant and CEO of MeddiQuest Limited, a U.K. based regulatory affairs management company. Neil has over 30 years of healthcare industry experience in engineering, manufacturing, quality and regulatory affairs roles, with leading medical technology companies such as Smiths Medical, Teleflex Inc. and The Automation Partnership.

Neil has served on the board of directors of TOPRA (The Organization of Professionals in Regulatory Affairs) and on the manufacturing board of the Institution of Engineering and Technology (IET). Neil has also led the global track at the RAPS (Regulatory Affairs Professionals Society) Annual Conference in Washington and chaired the device track at the RAPS European Conference in Paris and was a member of the RAPS Ethics Task Force.

Neil is registered as a European Engineer, a Fellow of RAPS and a Fellow and Medical Device Network Chair of TOPRA, and Chair of the Chartered Quality Institute’s Medical Technology Quality Group (having also served on the Professional Policy Board). Neil is also a mentor for young engineers through the IET and lectures on the Medical Technology Regulatory Affairs M.Sc. Course at Cranfield University.

Who should attend?

• Regulatory Directors & Managers
• Regulatory Associates & Specialists
• Quality Directors & Managers
• Quality Associates & Specialists
• Compliance Directors & Managers
• Compliance Associates & Specialists
• Software Engineers & Developers
• Software Managers
• Project Engineers
• Project Managers
• Design Engineers
• Design Managers