Software Design Controls in Life Sciences Applications

This webinar will discuss the latest global medical device design controls requirements for software in a medical device (SiMD) and software as a medical device (SaMD). Each requirement pulled from U.S. and global standards and guidance (e.g. IEC 62304, IEC 82304, IMDRF SaMD Guidance, AAMI TIR45) will be explored to fashion a complete picture of activities, document content, and dependencies across a variety of lifecycle development models. The session will also include special topics such as evolving cybersecurity requirements, the relationship of software design controls to non-medical device applications, and proposed regulatory frameworks for AI/ML systems.

Why Should You Attend:

Global regulatory authorities are increasingly focused on poor software design, implementation, and verification during product submissions and onsite inspections and audits. Regulatory investigators and notified bodies are improving their level of technical competence and tightening their expectations for software process maturity. Failure to follow existing and ever-evolving design controls requirements can and has led to declined product submissions, inspection observations, and regulatory enforcement action.

This intensity is driven by the significant share of product recalls driven by software defects, increased frequency and impact of malicious cyber attacks, and the failure of companies to manage the design, testing, and changes in their software systems to ensure continued safety and efficacy.

This webinar provides a valuable overview of the regulatory landscape for medical device software and supplies tools a company can use to fashion their procedures and practices around compliance, safety, efficacy, and sound software engineering. As the regulatory environment struggles to keep pace with the technological environment applied to life science applications, the session will speak to the future and how to prepare for what is next from interested third parties.

Learning Objectives:

• The categorization of regulated software in the life sciences
• The current challenges in medical device software
• An overview of existing regulatory literature as applied to design controls generally and to software design controls specifically
• A detailed walkthrough of software design controls activities and deliverables required by existing standards and guidance
• The application of risk management to software
• The application of software design controls requirements in waterfall and iterative lifecycle models
• The assessment and treatment of legacy software
• Technical reviews as a component of software verification
• The fallacy of defect-free software
• Impact analysis and change management
• Defending software design controls during submissions and inspections
• Cybersecurity as a sub-component of software design controls and risk management
• The current and future treatment of AI/ML systems in life sciences applications

Areas Covered in the Webinar:

• 0:00 - 0:30: Introduction and categorization of regulated software
• 0:30 - 1:00: Design controls and software design controls regulatory literature
• 1:00 - 2:00: Design controls basics and software design controls overview
• 2:00 - 3:00: Software design controls detailed requirements
• 3:00 - 3:30: Special topics (cybersecurity, AI/ML, inspection/audit defense)
• 3:30 - 4:00: Wrap-up and Q&A

Who Will Benefit:

• VPs, Directors, and Managers of Software Development and Engineering
• VPs, Directors, and Managers of Quality
• VPs, Directors, and Managers of Regulatory Affairs
• General Counsels of medical device companies