IEC 62304: Software Lifecycle

This training aims to bring a complete overview of the implementation of the IEC 62304 for the development of a software as a medical device. The regulatory context will be discussed, the integration of software aspects within a medical device are reviewed and all aspects associated to IEC 62304 will be presented in order to be able to implement a compliant software development process.

The main objectives are:

  • Present the key concepts related to the development of software for a medical device
  • Identify medical devices when working with a standalone software
  • Present all requirements associated with IEC 62304
  • Present the necessary modifications in the Quality Management System in order to sustain a software development process compliant to IEC 62304
  • Review recommended verification and validations activities for software development
  • Present a documentation structure and content to be included in a Medical Device Technical Documentation prepared for regulatory submission

The following topic will be addressed during this two days course:

  • Regulatory considerations (EU and US rules and guidance)
  • Software as a medical device
  • IEC 62304 and other standards
  • Key concept associated with IEC 62304
  • Review of the standard requirement
  • Compliant development process
  • Software risk analysis
  • Technical file and quality documentation
  • Cybersecurity and medical device software 

Who should attend

  • Quality Manager to understand the impact of the standards on their QMS
  • Design and software engineers to understand the expectation of the IEC 62304 with regards to the development process
  • Team leaders and product managers to understand how requirements related to IEC 62304 affects their design team
  • Risk Managers to integrate risk classification and software risk identification aspects in their process
  • Anyone who is interested to understand the requirements associated with software on medical device development and validation

Dr. William Enns-Bray, Project Associate, Medidee Services SA

"I liked the material and the exercise"

"Good discussions, excercises and instructor"

"The trainer was very skilled within the topic and with a very good English"

"Good comprehensive course. Lots of good insights from the instructor"

"I liked the discussion of exercises"

Participants, Spring 2020 

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mp@medicoindustrien.dks billede
Morten Petersen