7:30 am Morning Registration

8:20 am Chair’s Opening Remarks

  • Pat Baird Senior Regulatory Specialist – Head of Global Software Standards , Philips

Innovation v Compliance


The medical device space is facing rapid technology advancements from innovations from AI/ML to
wearable devices. While such progressions is pushing the space forward, these transformations aren’t
always compatible with current regulations. This conflict needs to be addressed to prevent the hindering of innovation. The following case studies address this key challenge.

Understanding & Navigating Global Regulations

8:30 am Opening Panel: Overcoming the Challenges of a Fast-Paced Software World and a Slow-Paced Regulatory World

  • Wendy Ji Principal Verification Software Engineer, Medtronic
  • Rosalind Beasley VP Digital Innovation, Dot Compliance Inc
  • Ashley Miller Director of Regulatory Affairs, Digital Diagnostics


  • Outlining ideas for situations where innovation is hampered by compliance constraints
  • Understanding the evolving pre and post market expectations
  • Discussing the first steps to take when your medical device software isn’t globally compliant

9:15 am Cybersecurity Vulnerability Management, SBOMs and Compliance


  • Regulatory Update for Medical Device Cybersecurity
  • Potential Pitfalls from the Supply Chain and in Development Lifecycle
  • Real Use Cases for Significantly Reducing Cybersecurity Risk

9:45 am FDA insights on the regulation of Artificial Intelligence/Machine Learning’

  • Brendan O’Leary Acting Director, CDRH Digital Health Center of Excellence, U.S. Food and Drug Administration


  • Proposed regulatory framework for modifications to AI/ML
  • Allowing for modifications to be made from real-world learning and adaptation
  • Ensuring that the safety and effectiveness is maintained

10:15 am Morning Break & Structured Networking

Maintaining Compliance When Implementing New Technologies

11:15 am Outlining Optimal Methodology of Managing Compliance for SOUPs, CSV & Tools


  • Identifying QMS applicability
  • Classifying product or non-product software
  • Implementing strategy & documentation
  • Maintaining configuration management & revalidation requirements

11:45 am Understanding How to Classify Software within Global Frameworks

  • Jeff McBride Chairman and Founder of the Panacea Community and SW Quality Specialist European Device Solutions , AAMI


  • Defining a medical device when the metrics aren’t clear-cut, and knowing what classification to use
  • Implementing a risk-based approach
  • Additional considerations for when the software resides in the Cloud and uses AI-ML

12:15 pm End-to-End Case Study on Getting FDA Approval for AI SaMD


  • Designing AI enabled SaMD – what are the key considerations?
  • Understanding clinical validation of AI SaMD
  • Outlining documentation for regulatory submission specifically for AI

12:45 pm Lunch & Networking

1:45 pm Panel Discussion: Discussing the Different Applications for AI-ML in Healthcare


  • Identifying applications across diseases and diagnosis
  • Defining AI success for product approvals and regulatory inspections
  • Discussing machine learning-based behavioural modification

2:30 pm Panel Discussion: Filling the Gaps of Knowledge for New Software Developers in the Industry


  • Understanding how a team can design innovative device software with stricter regulation in mind from the outset
  • Implementing internal training to build team expertise at all levels
  • Creating rapid Agile techniques for effective software build

Improving Innovation with Agile Software Development

3:15 pm Using Agile Development for Medical Devices Systems – Guidance from AAMI TIR45


  • Aligning Agile concepts with Design Control Requirements and the IEC
    62304 Standard
  • Managing change with incremental/evolutionary development
    of requirements
  • Embracing continuous integration, verification, and validation practices

3:45 pm Afternoon Break & Networking

4:05 pm Test Planning for a Medical Device

  • Wendy Ji Principal Verification Software Engineer, Medtronic


  • Understanding how to plan for risk management
  • Knowing which requirements to meet
  • Planning for Agile development


4:35 pm Panel Discussion: Understanding Key Challenges & Solutions of Agile Methodology


  • Understanding the challenges of applying Agile in a regulated environment and deciding how to adjust to the
  • Exploring software that controls hardware in an Agile world
  • Discovering the differences between consumer and medical device space

5:20 pm Chair’s Closing Remarks

  • Pat Baird Senior Regulatory Specialist – Head of Global Software Standards , Philips

5:30 pm Drinks Reception