Reclassification of Software Automated Medical Devices

Faculty: José Mora ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: MD2289

  • Date:2/26/2025 11:00 AM - 2/26/2025 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event
 

Description

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.


Why You Should Attend:

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, learn how to adapt to shifting regulatory landscapes, 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. Stay ahead in the rapidly advancing world of digital health innovation.


Areas Covered:

  • Introduction to software-automated medical devices and their various types
  • Overview of key regulatory authorities like FDA, EMA, and other global agencies
  • Understanding classification frameworks and regulatory criteria for these devices
  • Challenges in classification, reclassification, and regulatory approval processes
  • Compliance requirements and the impact of classification on market access
  • International harmonization efforts and their role in regulatory alignment
  • Discussion on proposed reclassification frameworks and their implications
  • Practical strategies to navigate evolving regulations and ensure compliance


Who Should Attend:

  • Senior and middle management
  • Quality Assurance
  • Research and Development
  • Manufacturing
  • Production
  • Engineering
  • Design Engineers
  • Design Assurance

Course Director: JOSÉ MORA

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 working full time as a consulting partner for 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. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.

José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter.

His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under José’’s leadership.

He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.