Learning objectives

Are you responsible for the development of quality management of medical device software, either for (embedded) medical device software or for (stand-alone) software as a medical device (SaMD)? Is an audit pending? If so, you should attend the seminar! Here’s how you will benefit from the seminar:

  • Regulatory foundations: You know the relevant standards, laws, regulations, and directives
  • Process models: You will learn how to keep agile software development compliant with standards and laws
  • IEC 62304 and FDA: You will be able to create lean and concise documentation meeting the requirements of IEC 62304 and of the FDA
  • SOUP and legacy software: You will know how to comply with IEC-62304 regulations when selecting, integrating, and documenting software of third parties or dealing with legacy software
  • Risk management: You will understand the interaction of risk management (according to ISO 14971) on the one hand and IEC 62304 respectively FDA requirements on the other hand. This includes the determination of “software safety classes” respectively “levels of concern” and segregation of software  systems and components
  • Quality management: You will be given a heads-up to streamline your quality management system and to master your audit.

This seminar is a concise introduction to the topics of development, quality assurance, and approval of medical software (stand-alone software or medical device software). It especially addresses everyone aiming at getting a quick and comprehensive overview of the following topics.

Time Topic
09:00 Beginning of the seminar
09:00 Expectations, introduction
09:30 Relevant standards, laws, regulations, and their interactions
10:00 Medical Device Directive (MDD, 93/42/EC), Medical device regulation (MDR), national laws and regulations, essential requirements
10:30 Break
10:45 When is software classified as a medical device?
11:15 Approval procedures in Europe and the USA
11:45 Overview of IEC 62304, Software Requirements Specification (I)
12:30 Lunch
13:30 Software Requirements Specification (II)
14:00 Software Architecture
15:00 Break
15:15 SOUP/OTS, software classification, software risk management
15:45 Software development process, agile development
16:30 Additional FDA requirements, software verification, and validation
17:15 Official end
17:15 Questions and answers session, typically until 18:00

The Paramount of this seminar is practical relevance. Participants will learn how to quickly fulfill requirements (e.g. IEC 62304, FDA) without creating a QM bureaucracy.

The lectures are alternating with case studies and exercises. We limit the maximum number of participants to 16 to ensure learning success and having enough time to respond to individual questions.

Target Audience

The seminar “medical software” addresses everyone involved in software development for medical devices compliant with standards, both regarding stand-alone software and software being part of a medical device. Addressed are especially

  • software developers, software architects
  • project leaders, product owners, SCRUM masters
  • persons in charge of regulatory affairs and quality management

Questions, Further Information, In-house Seminars

Please click here for further information on

  • upcoming dates,
  • costs,
  • registration,
  • journey and
  • accommodation.

Do you have any questions or suggestions? Do you want to carry out the seminar as an inhouse-seminar, to tailor the topics to your individual needs? Contact us directly. We are looking forward to it!

Comments of Previous Participants

  • “Prof. Thomas stands out significantly due to his “passion for presenting and teaching”. Accordingly, the atmosphere during the seminar is good. Sensitization for the complex (and potentially far-reaching!) topic is well done all around. The seminar will be compulsory for all our engineers romping around the environment of the medical device. In addition, I’m looking forward to being further inspired.”
  • “Vivid, enthusiastic presentation of a complex topic…”
  • “It is excellent to gather knowledge and experience from a competent speaker”
  • “I especially liked the presentation of degrees of obligations, dependencies of standards and specific assignments of provisions in the standards to phases”
  • “Excellent practical experiences”
  • “Sensational presentation!!!”
  • “The selection of topics was spot-on”
  • “Vivid delivery, involvement of participants and their questions”