Workshop: Software validation for medical devices

Contents:

• Introduction, terms and definitions
• Regulatory requirements (legal, normative)
• Usability validation: Compliant with IEC 62366-1 and IEC 82304-1
• Software validation and risk management
• Documentation requirements (ISO/IEC/IEEE 15289:2019)
• Intensification through best practice examples

Short biography of the speaker:

Julian Alpers holds a Master of Science in Computational Visualistics from Otto von Guericke University Magdeburg, which he completed from October 2011 to May 2018. After graduating, he worked as a software developer at Surpath Medical GmbH in Würzburg from September 2017 to October 2018. There he gained experience in VTC and image processing and completed a five-month assignment abroad in China.

From November 2018 to December 2022, he was a research doctoral student at Otto von Guericke University Magdeburg, specialising in minimally invasive imaging and developing expertise in Python and C++. From July 2021 to July 2023, he worked as a software project manager at InLine-Med GmbH in Magdeburg, where he managed medical imaging projects and implemented and coordinated the implementation of IEC 62304.

Since October 2023, Julian Alpers has been working at seleon GmbH and specialises in the software life cycle, product safety within the framework of IEC 81001-5-1, MDCG 2019-16 and the relevant FDA Guidances, as well as in the area of artificial intelligence in software and dealing with the AI Act.

Costs:

• €100 for biosaxony members
• €150 for non-members

The webinar will be held in English.

Register now and send an email to katja.krempler@leap-up.com!