Compact Seminar Compliant medical device software development

Teaching goals

The one-day compact seminar aims to increase your competence in the practical implementation of regulatory requirements (in particular IEC 62304) while promoting efficient software development. You are responsible for the development or quality assurance of medical device software or software as a medical device (SaMD)? Then you should attend this seminar!

  • Regulatory basics: You know the relevant guidelines, directives, laws, standards, regulations and their interaction
  • Process: You know the development activities of the IEC 62304 and how to match agile development with this standard
  • Documentation: You create lean and accurate documents that meet the requirements of IEC 62304 (e.g. software requirements, software architecture and software design)
  • SOUP: You know how to select, integrate and document third-party software in an IEC 62304 compliant manner.
  • Software risk management: You understand the interaction of risk management according to ISO 14971 and IEC 62304 and the definition of safety classes and segregation
  • Quality management: You have the starting points to streamline your quality management system and pass your audit with confidence

Content

This seminar is a compact introduction to the topic of development, quality assurance and approval of medical software (software as a medical device or medical device software). It is especially aimed at those who want to get a quick and comprehensive overview of the following topics:

 

Time Topic
9:00 AM Start of the seminar
9:00 AM Expectations, introduction
9:30 AM Relevant standards, laws and directives and their interrelationships
10:00 AM Medical Device Regulation (MDR, 2017/745), National laws and regulations, Basic requirements according to Annex I
10:30 AM Break
10:45 AM When does software become a medical device?
11:15 AM Approval procedures in Europe and USA
11:45 AM Overview IEC 62304, Software Requirements Specification (I)
12:30 PM Lunch
1:30 PM Software Requirements Specification (II)
2:00 PM Software Architecture
3:00 PM Break
3:15 PM SOUP, security classification and interaction with risk management according to ISO 14971
3:45 PM Software development process, agile development
4:30 PM Deepening or/and desired topics of the participants e.g. differences to FDA requirements, or test documentation
5:15 PM Official end
5:15 PM Answering individual questions, typically until 18:00

 

The seminar focuses on practical aspects. Participants learn to implement the requirements of IEC 62304 without QM bureaucracy.

The lectures alternate with case studies and exercises. We limit the number of participants to a maximum of 16 to ensure learning success and to have enough time for answering individual questions.

Target group

The seminar "Compliant medical device software development" is intended for all persons involved in the standard-compliant software development of medical devices, both standalone software and software that is part of a medical device. In particular

  • Software developers
  • Software architects
  • (Software) project managers
  • Persons responsible for regulatory affairs and quality management
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