"TIR45: Guidance on Incorporating Agile Practices in the Development of Medical Device Software" originally debuted in 2012, aiming to aid organizations involved in medical device software in effectively applying Agile methodologies while maintaining alignment with stringent medical device regulations (e.g., FDA 21CFR820, ISO 13485) and established software development standards (primarily IEC 62304).

The eagerly awaited second edition responds to the growing needs of the community, addressing key inquiries and offering comprehensive insights. It delves into various critical aspects, including adapting documentation strategies to the digital landscape, streamlining approval processes and signature requirements, showcasing the value infusion of Agile mechanisms in upholding quality and compliance, and navigating the integration of pivotal undertakings like cybersecurity, risk management, design validation, and human factors/usability within an Agile framework.

This course, built upon the foundational comprehension of the inaugural edition (TIR45:2012), serves as a beacon guiding manufacturers. It illuminates the novel facets introduced in the second edition, empowering these manufacturers to harness the complete spectrum of benefits that Agile development profoundly offers.

Over the course of (3) hours, the attendee will be able to:

• Understand how Agile practices align with medical device regulations and software development standards, and their value for quality and compliance.
• Analyze the integration of cybersecurity, risk management, design validation, and human factors/usability within an Agile framework.
• Apply strategies from the second edition of TIR45 to enhance Agile-based medical device software development, and effectively communicate Agile benefits to stakeholders.

Medical Device and Pharmaceutical professionals with various experience in one or more of the following areas: Software Engineering, Software Quality, Regulatory or Compliance.