Software Design Controls in Life Sciences Applications

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

Eric Henry
Senior Quality Systems and Compliance Advisor, King and Spalding LLP

Eric Henry is a Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding. Eric is a 30-year industry veteran having led and coached global organizations through a wide variety of quality and compliance challenges. Complementing his leadership experience is an extensive hands-on skillset including audit management and response, Quality System remediation, software quality (including cybersecurity and AI/ML), medical device design controls, risk management, and regulatory due diligence.<,p>

Prior to King & Spalding, Eric led global technical and quality functions at Philips, Medtronic, GE Healthcare, Boston Scientific, and Hologic.

Prior to entering the medical device industry, Eric led a software quality management and program management office consulting capability in the Washington, DC area and held software design and development leadership roles in a small startup, a mid-size healthcare software company, a large financial services regulator and stock market, and a large retail organization.

Topic Background:

Whether software is embedded in an electro-mechanical medical device, driving the user interface to a medical device, or a stand-alone medical device in its own right, it is subject to design controls requirements defined by a global set of regulations, standards, and guidance. This webinar will place software design controls within the wider design controls regulatory context, while providing a detailed walkthrough of the primary regulatory requirements, as they might be applied in a wide variety of waterfall or iterative lifecycle models.

Building on the basic design controls requirements of 21 CFR Part 820 and ISO 13485, specific activities and deliverables will be discussed based on international standards such as IEC 62304 and detailed guidance from organizations such as the U.S. FDA, AAMI, IMDRF, the Australian TGA, and Health Canada. Sub-topics will include regulatory expectations of cybersecurity, the myth of defect-free software, and the importance of impact analysis to software change management.

The session will also address specific applications of software design controls that may be beneficial in non-medical device environments, mobile medical applications, and AI/ML systems.

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