Agile in MedTech: Essential best practices, and how to support them
Medical device development with its regulatory requirements is often viewed unsuited for Agile methods. There does seem to be a natural tension between commonplace Agile practices and regulatory compliance requirements in MedTech. However, these challenges can be overcome, unlocking Agile’s potential to bring important benefits to the development of medical devices.
This presentation introduces specific Agile practices, i.e., methods, workflows, templates etc., that are particularly important for medical device development. Examples are: using a Definition of Done for managing regulatory constraints, establishing traceability between agile work items, and building compliance incrementally.
The presentation explains how these practices can be introduced, and how they can be supported effectively through state-of-the-art tool infrastructures. Important building blocks are consistent requirements management and traceability, seamless agile workflow support, and a quality management system (QMS) that is based on agile principles. The practices and recommendations are substantiated by experiences from leading healthcare organizations.
Referent: Atef Ghribi, Intland GmbH
Co-Autor: Dr. Andreas Birk, Software.Process.Management
Atef Ghribi started his career in the consulting industry after successfully completing his studies in Information Systems at the Universities of Stuttgart & Hohenheim in Germany. There, he focused on systems engineering topics to develop solution concepts for processes, methods, and tools. He was involved in several projects and initiatives to optimize modern product development processes as a certified systems engineer & ASPICE assessor. Since March 2021, he started working at Intland Software as a Solution Engineer. In this function, he supports customers from all industries in using Intland's tools to solve the challenges they face in modern product development.
Dr. Andreas Birk is founder and principal consultant of Software.Process.Management. He helps organizations optimally design and improve their software development processes. His focus areas are software product management, agile development, and tool-based requirements management.
Datum und Uhrzeit: 20. Oktober 2021, 12:30 bis 13:15