- Speaker : José Mora
- Session Code : JAJAN3023
- Date : 30th January 2025
- Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
- Duration : 90 Mins
Reclassification of Software Automated Medical Devices
Overview:
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.
Areas
covered in the session:
- 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
Why
Should You Attend?
As
the life sciences industry integrates advanced technologies into medical
devices, navigating regulatory classifications has become increasingly complex.
Attending this webinar will provide you with a comprehensive understanding of
how regulatory frameworks categorize software-automated medical devices and the
implications for compliance, safety, and market access.
You’ll
gain insights into the challenges posed by reclassification, learn about global
efforts toward harmonization, and explore practical strategies to adapt to
evolving regulations. This session will empower you to stay ahead in the
competitive landscape, ensuring your devices not only meet stringent regulatory
requirements but also achieve faster market entry.
Whether
you’re a seasoned professional or new to the field, this webinar will help you
grasp critical concepts, anticipate potential roadblocks, and implement best
practices for successful device classification and compliance.
Who
will benefit?
This
session is ideal for professionals involved in the development, regulation, and
marketing of software-automated medical devices, including:
- Regulatory
Affairs Specialists
- Quality
Assurance Professionals
- Medical
Device Manufacturers
- Product
Development Managers
- Compliance
Officers
- Healthcare
Technology Innovators
- Software
Engineers in the Medical Device Industry
- Legal
and Compliance Counsel
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 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.