Medical Device Software Compliance Requirements

Qualifying People - Developing Future

Qualifying People - Developing Future

about the Course 

The implementation of IEC 62304 and other applicable software standards such as IEC 81001-5-1, IEC TR 60601-4-5 and IEC 82304-1 are a challenge for many manufacturers of medical devices. Consisting of a whole range of process and product relevant requirements that are essential for the compliance of medical device software to the regulatory requirements. The training program provides an overview of the required processes describing the software life cycle. The aim of the training program is to learn the requirements for the development and approval of medical software and to be able to implement them for one's own application.

Course objectives

  • Provide a high-level understanding of the software and cybersecurity requirements related to Medical Devices.
  • Processes describing software lifecycle.
  • How to decide on the “State of the Art” (STOA)
  • Learn how to implement cybersecurity requirements in the software lifecycle

Course content/outline

  • Introduction to Medical Device Software
  • Requirements for conformity assessment procedure for medical device software
  • The role of International Standards
  • How to decide on the State of the Art (STOA)
  • Requirements based on IEC 62304
  • Requirements based on IEC 82304
  • Cybersecurity in Medical Devices – How to implement cybersecurity requirements in the software lifecycle?
  • The risks and opportunities of artificial intelligence (AI) in Medical Devices
  • Controlling the development of AI in Medical Devices in the future – Regulators around the world

Training duration

1 Day. Note: Classroom discussions will be spread over the entire day. 


Preferred to have basic knowledge of Quality Management System and / or experience in medical device operations.


An attendance certificate would be provided to the attendees from TÜV SÜD South Asia. 

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