M. Cyrille Michaud
Durée de la formation
ISO 14971 risk management is a key process of medical devices activities. FDA reported that 24% of adverse events in 2011 were raised by a software failure. Given the complexity of software design, companies and managers expect hard times when the come to apply risk management to software.
Software has its own rules and concepts that are related to risk management: software, failure, bugs, defects and user errors. These concepts and the way to handle them have a significant influence on the risk management process. Knowing how to combine an ISO 14971 compliant risk management process with activities of software development and maintenance is the key factor to your success in the software medical device industry.
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 the concepts of software risk management: risks, software failures, bugs.
Learn how to assess software risks.
Learn how to produce mandatory documentation, while being agile.
Learn how to combine risk management with software development process.
Learn how to manage risks in software maintenance.
Preliminary focus on ISO 14971, a reminder of the risk management process
Concepts of software risk management complementary to ISO 14971
Risk management process combined with IEC 62304 software development process
Risk management process applied to SOUP (software of unknown provenance)
Focus on methods to reduce probability of software failures and defects
Risk management during software maintenance