Medical devices need professional software engineering. Rising quality demands, increasing exposure to cybersecurity attacks as well as heavy cost pressure in the public health sector demand good yet efficient processes for developing medical equipment.
This one-day primer provides the necessary overview to medical software engineering. It starts with the relevant standards such as ISO 14971 (risk management), ISO 13485 (QM), IEC 62304 (lifecycle), IEC 60601 (medical products), Medical SPICE and FDA. Current development best practices are systematically introduced with hands-on case studies. A focus is given to risk-oriented development. Current topics such as scaling agile for medical products, cybersecurity hardening, penetration testing for medical devices, and the necessary development tools are covered. The training provides hands-on insights for standard-oriented development in line with regulatory demands. It ensures the basic understanding of state-of-the-practice methods.
"High quality of work in the shortest possible time"
- Dr. Oliver Koester, Yazaki
"The strategic partner for optimizing our engineering"
- Joachim Missel, Daimler
Content and Agenda
Introduction Medical Devices Software Development
Exercises and benchmarks
Best practice from various industries and case studies from Vector projects
700 € plus VAT (1 Day)
Admission price includes full documentation on paper and as PDF . Naturally, all participants benefit from our rich coffee breaks and a quality lunch in our spectacular Vector restaurant. Each participant will receive a qualifying Vector certificate for this intensive training.
Get a 10% discount (can be combined):
for open online training until June 2021
if you register more than 2 participants of your company
if you book at least 60 days in advance
Full-time students receive a (non-combinable) discount of 70% (on presentation of a valid student card).
Do you want to adapt this training to your own examples and challenges? Looking for a workout that delivers practical exercises adjusted to your environment? Then, we suggest that you have this training conducted in-house, where you can decide on focus, speed and the training schedule. We also offer dedicated crash courses for employees and management.
Language: German or English.
On request, we offer our inhouse trainings in Chinese, French, Korean and Turkish.
This training targets medical developers and managers, testers, Quality engineers and managers from companies of all industries and sizes.
About our Trainers
Dr. Ulrich Bodenhausen is a consultant at Vector Consulting Services. He is a renowned expert on agility for critical systems. Previously he worked as a project manager in development projects. Dr. Bodenhausen supports companies worldwide to improve their development processes and change management. He works across industries in the field of engineering methods, agile and lean methods, requirements engineering, and to improve efficiency.
Prof. Dr. Christof Ebert is Managing Director of Vector Consulting Services GmbH. He supports companies worldwide in improving their product development and product strategy as well as in change management. He sits on various supervisory boards, is a professor at the University of Stuttgart and the Sorbonne in Paris, and the author of several renowned books. Twitter: @ChristofEbert.