About the Conference

Medical device software, whether embedded or part of a connected system, is increasingly prevalent and also an increasing cause of problems and enforcement actions. RA/QA, product development engineers, and compliance officers can have difficulty with what often seems like a black box, and working with programmers who have different cultures, vocabularies, methods, and expectations.

This unique conference on medical device software for non-software professionals brings together diverse experts experienced in bridging the gaps and providing knowledge and tools to help oversee medical device software and connected systems throughout the product life cycle, from optimizing a collaborative development process through validation, risk management, and postmarket surveillance and modifications. No software experience is necessary.

What you will learn:

  • Effective procedures for developing embedded software in medical devices
  • Common problems and disconnects with medical device software
  • Creating efficient teams for implementing software development
  • US and global software regulations and standards
  • Quality and compliance oversight of medical device software
  • Software human factors and usability considerations
  • Advantages and pitfalls of integrating off-the-shelf software
  • Validating software
  • Medical devices vs Medical Device Data Systems (MDDS)
  • Postmarket surveillance of software changes and issues
  • Risk management and software

CEU Information

Attendees can earn CEUs. 1 hour of the conference = .1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.


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