M. Cyrille Michaud
Durée de la formation
Many firms want to apply IEC 62304 while developing their products with modern agile methods. At first glance, IEC 62304 standard describes a process tightly linked to the waterfall model. But it is doesn’t mention that this model is mandatory.
However, no information is given about applying agile methods. Yet, it’s possible to apply IEC 62304 with agile methods. Some firms have already switched from waterfall to agile without loosing their compliance to the standard.
Knowing how to combine the agile methods with IEC 62304 is the key factor to your success in a fast changing software medical device industry.
People with a background in software development and knowledge of IEC 62304, working for medical devices or in vitro diagnosis manufacturers:
Quality Assurance and Regulatory Affairs Managers,
Software Project Managers,
Software Development, Risk Management, and Test Engineers.
Objectif de la formation
Learn how to develop software medical devices with agile methods.
Learn how to keep your risk management process effective and efficient.
Learn how to produce mandatory documentation, while being agile.
Learn how to maintain software medical devices with agile methods.
Learn what documents you should write to prove compliance to the standard.
From waterfall to agile
Agile development compliant with IEC 62304
Agile software risk management compliant with ISO 14971