Medical device manufacturers have in recent years expanded their product portfolio with digital solutions and added connectivity to their previously standalone devices. Regulatory bodies have kept the pace and updated their regulations to reflect this new reality. What do these new regulations mean for manufacturers making their move into the digital world? When is software a medical device or accessory, and what are the implications on the design and development activities? How can we design software to develop software in an agile way along architecture best practices that meets the time-to-market, requirements from the regulatory bodies, and utilizes state-of-the-art technologies and frameworks?

Who should attend?

Anybody involved in the development of medical device software and would like to get a
better understanding of the implications on product design activities. For example:
• Software Engineers
• Software System and Solution Architects
• Engineering Managers
• Requirements Engineers
• Regulatory Experts
• Software Testers
• Risk Managers

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