Reclassification of Software Automated Medical Devices
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Speaker : JOSE IGNACIO MORA
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When : Thursday, February 19, 2026
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Time : 01 : 00 PM EST
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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, 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 Jose’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.
Without continuous improvement, you are at risk of going out of business and quickly. Yet, with many, and mostly expensive continuous improvement methodologies, it is expensive and hard to implement and drive continuous improvement in any organization.
Hence, going back to the basics is the solution - and the best solution, if you want to achieve your corporate objectives and beat the competition.
Areas Covered
- Introductions
- Introduction of the types of software automated medical devices and regulatory authorities
- Discussion of the classification framework and criteria, of regulatory and reclassification challenges, and of compliance and international harmonization
- Discussion of the proposed reclassification framework
- Questions and answers
Who Should Attend
Managers, Supervisors, Directors, Engineers, and Vice-Presidents in the areas of:
- Manufacturing Engineering
- Quality Assurance
- Operations Excellence
Topic Background
Software-automated medical devices are tools or systems that rely on software algorithms to carry out tasks traditionally performed by healthcare professionals or to improve the accuracy and efficiency of medical procedures. These devices vary in complexity, from simpler applications like automated insulin delivery systems to sophisticated solutions like robotic surgical assistants.
The classification of software-automated medical devices is determined by regulatory agencies, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national authorities. These frameworks categorize devices based on patient risk levels and the software's intended purpose, impacting the regulatory requirements for approval, oversight, and market access.
Proper classification is essential as it directly affects regulatory requirements, safety standards, effectiveness, and the market access of these devices. Key factors that highlight the importance of classification include patient safety, regulatory oversight, innovation, market access, and adapting to technological advancements.
To ensure compliance and promote global consistency in reclassifying software-automated medical devices, coordination among regulatory authorities, manufacturers, and qualified professionals is needed. There may be pathways toward achieving international harmonization and regulatory compliance.
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$199.00
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