Design & Validate Compliant, Innovative & Secure Medical Device Software
Welcome to the 4th Annual Medical Device Software Development Summit 2024
As the FDA finalizes updated guidance on cybersecurity, the integration of AI and ML into software development raises more questions than answers, and gold standard software development becomes outdated more and more quickly, it has never been more critical to stay ahead of the curve.
The Medical Device Software Development Summit 2024 offers invaluable insights for navigating the intricacies of the highly regulated and fiercely competitive medical device sector. Tailored to alleviate the challenges of balancing R&D innovation with regulatory compliance, this summit will be uniting industry Key Opinion Leaders to share their diversified knowledge over this comprehensive 3-day program. Dedicated to interrogating crucial topics such as risk management, (cyber)security, submission pitfalls, compliance, global harmonization and PCCPs, this event will also cover:
- Exploring how AI in QMS can help to meet compliance along with improving efficiency.
- Implementing best practices to streamline documentation processes, striking the right balance between efficiency and satisfying regulatory requirements, ultimately saving valuable time.
- Building out a Software Bill of Materials for Embedded Packages, Open Source & Third-Party Software to Meet FDA Requirements and Ensure Regulatory Approval.
- Identifying and isolating pivotal deliverables outlined in the expansive SPDF guidance, simplifying the document for a more digestible and actionable understanding.
Join over 120 industry experts from esteemed organizations like Insulet, Abbott, Medtronic, GE Healthcare, Philips, and other as they uncover practical strategies to align Agile methodologies, enhance product compliance, and foster cross-functional collaboration, contributing to an industry-wide effort to balance robust regulations with fast-paced innovations.
2024 Expert Speakers Include:
Principal Cyber Security Architect
System Software Engineer
Director of Regulatory Affairs, Software
Baxter International Inc.
Here are a Few of the 20+ Case Studies Shared at the 2023 Summit:
The FDA Expectations on Cybersecurity in Device Development and How to Embed Cybersecurity Across the Total Product Lifecycle
Linda Ricci, MME MPH Director, Division of All Hazard Response, Science and Strategic Partnerships, FDA
A Deep Dive into the AI Regulatory and Standards Landscape Including Cybersecurity
Pat Baird, Senior Regulatory Specialist, Philips
How to Rethink Regulatory Processes & Reduce Ambiguity Around FDA Guidelines for SaMD Devices
Anthony Watson, Vice President of Regulatory Affairs & Quality, Pear Therapeutics
Best Practice for Medical Device Software Maintenance Including Patching, Field Bugs & Expanding Lifespan
Bemin Ghobreal, PhD, R&D Software Engineering Manager of Surgical Robotics, Medtronic
A Comparison of the Lean Startup Version of SaMD to SaFe Approach (Startups vs Large Corporation). Scaled Agile & Lean Startup Meets SaMD
Greg Stern, Director of Product (SaMD), Insulet
The Use of Real World Evidence & Open Source in the Development of SaMD for Regulatory Approval
Tapani Otala, Vice President of Engineering, Tidepool