Workshop on Agile Methods in Regulated Domains

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Agile software development methods are widely adopted in the software industry. However, it is still often assumed that they are not suited to regulated domains such as aerospace, automotive, pharma and the med tech sector, due to additional requirements for documentation and process compliance. This industry workshop features four experienced practitioners from Ireland, the UK, Sweden and Germany who have been pioneering the use of agile methods in sectors such as aerospace, automotive, pharma and life-sciences.


The workshop will feature three industry experts from different regulated domains:

  • HÅKAN KLEIJN is a lean and agile coach at Softhouse in Sweden. He has extensive experience in agile project management and standards such as ISO9000/15288, quality management systems and validation.
  • HANS-JÜRGEN KUGLER is Chief Scientist of Kugler Maag Cie GmbH in Germany. He has been involved in adaptation of the ISO/IEC 15504 SPICE standard to the automotive sector.
  • RYAN O’SULLIVAN is a senior project manager at QUMAS in Cork. His specialties include Scrum, PRINCE2, GAMP5. He helped to introduce Scrum project management in the regulated software development process of QUMAS.


The workshop will take place on March 14, 2014, from 10:00 to 13:00. Meet & Greet at 09:30, with coffee served. Please RSVP to


The workshop is organized and hosted by Lero, and will take place in the Tierney Building. Directions can be found here.

Can’t attend?

If you can’t attend the event but still would like to hear the speakers, you can follow the workshop on the webcast at: