Navigate the evolving regulatory landscape for software-driven medical devices — from FDA and EMA classification frameworks to reclassification strategies and accelerated market access.
Includes live access & recording
Software-automated medical devices are transforming healthcare by leveraging advanced algorithms to perform critical tasks traditionally handled by medical professionals. From automated insulin delivery systems to AI-powered diagnostic tools and robotic surgical assistants, these innovations enhance accuracy, efficiency, and patient outcomes.
However, their classification is a complex process dictated by regulatory bodies like the FDA, EMA, and other global authorities. These agencies assess devices based on patient risk levels, intended use, and potential impact on safety and efficacy — directly influencing approval, compliance requirements, and market access.
As the medical device landscape evolves, understanding the nuances of classification is crucial for ensuring regulatory alignment and maintaining a competitive edge.
Navigating regulatory classifications for software-driven medical devices is more challenging than ever, with evolving global standards, reclassification hurdles, and the push for international harmonization.
This webinar offers an in-depth look at the latest classification frameworks, their impact on compliance, and strategies for accelerating market entry. You'll gain expert insights into risk-based categorizations and explore practical approaches to streamline approval processes.
Whether you're a regulatory affairs professional, medical device manufacturer, or compliance expert, this session equips you with actionable knowledge to optimize device classification, mitigate regulatory risks, and ensure seamless market access.
Four focused areas that will strengthen your organization's approach to software medical device classification and compliance.
Deep-dive into FDA, EMA, and global regulatory criteria for software-automated medical devices, including risk-based categorizations and intended use assessments.
Understand proposed reclassification frameworks, common approval hurdles, and proven strategies for navigating the reclassification process efficiently.
Explore global harmonization efforts and how aligning with international standards can reduce duplication, accelerate timelines, and simplify multi-market submissions.
Gain practical strategies to streamline regulatory approvals, mitigate compliance risks, and bring innovative software-automated devices to market faster.
Eight critical topics spanning the full regulatory lifecycle of software-automated medical devices.
Professionals across medical device manufacturing, regulatory affairs, quality, and engineering who work with or are responsible for software-driven devices.
Senior and Middle Management
Quality Assurance
Research and Development
Manufacturing
Production
Engineering
Design Engineers
Design Assurance
The rapid proliferation of software-automated medical devices — from AI-powered diagnostics to autonomous drug delivery systems — has created significant regulatory complexity. Classification decisions made by the FDA, EMA, and other global bodies have far-reaching consequences: they determine a device's approval pathway, post-market obligations, labeling requirements, and ultimately its viability in key markets.
Regulatory agencies worldwide are actively revisiting existing classification frameworks to account for the unique characteristics of software-based devices. Proposed reclassification efforts reflect the need to balance patient safety with the pace of technological innovation, requiring manufacturers to continuously monitor and adapt to shifting requirements. Organizations that fail to anticipate these changes risk costly delays, remediation efforts, and loss of market access.
This webinar brings together regulatory intelligence and practical implementation guidance to help professionals stay ahead of the curve. By understanding the current and emerging classification landscape, attendees will be equipped to make informed strategic decisions, streamline their regulatory submissions, and ensure their software-automated devices remain compliant across international markets.
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry, specializing in manufacturing, process development, tooling, and quality systems.
Prior to consulting full time at Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem-solving, and quality system methodologies. He also led the launch of manufacturing at start-up urology products company UroSurge, Inc. at the University of Iowa's business incubator park — building a world-class medical device operation incorporating JIT, kanban systems, visual workplace, and lean manufacturing practices.
José spent 10 years at Cordis Corporation (now a Cardinal Health company), where he led the tooling, process development, and qualification of Cordis's first PTA catheter, and managed the Guiding Catheter Core Team — taking that business from fourth place to market leader. His device experience spans surgical instruments, PTA & PTCA catheters, plastic surgery implants, urology devices, brachytherapy delivery systems, orthopaedic implants, and vascular surgery grafts.
Throughout his career, José has introduced world-class methodologies including Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), and process validation to Global Harmonization Task Force standards.
Join José Mora for an expert-led session on navigating software medical device classification and staying ahead of global regulatory changes.