Software as Medical Device: Artificial Intelligence/Machine Learning

Instructor: James W Monroe
Product ID: 706461
Training Level: Advanced
  • Duration: 60 Min
This session will focus on conducting a risk/benefit analysis of both the positive and potential negative impact of the advancement of AI and ML devices in the medical device industry. It will provide a further understanding of the FDA's current thinking on the implementation of regulatory policies to ensure safe and effective medical devices that advance the quality of life of the patient. Artificial intelligence technology is rapidly spreading across the medical field, as systems are being developed that can identify signs of illness and disease in a wide variety of imaging situations such as MRI and CT. AI devices are complex with respect to algorithm used in their development, information being input in to the systems in which they learn, and the recommended out from such learning.
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Why Should You Attend:

Artificial intelligence technology is rapidly spreading across the medical field, as systems are being developed that can identify signs of illness and disease in a wide variety of imaging situations such as MRI and CT. AI devices are complex with respect to algorithm used in their development, information being input in to the systems in which they learn, and the recommended out from such learning.

  1. Can AI/ML be used in my business?
  2. Am I compliant with current regulations and guidance documents?
  3. What are the boundaries set by the FDA and other Regulatory Bodies?
  4. Will AI/ML replace the current standard of care with my company’s current standards of care?

Learning Objectives:

  • Upon completion, you will be able to identify the key input data that go into AI/ML training algorithms to develop clinical decision outputs.
  • You will be able to identify concerns of removing decision-making capabilities from the medical physician to an algorithm-based system that relies on or data to be input for its learning.
  • You will understand current US regulations, International Standards, and FDA’s current thinking on potential new regulations for developing safe and effective AI devices.

Areas Covered in the Webinar:

  • Differentiation between AI & ML
  • AI algorithmic bias
  • AI lack of transparency
  • Intelligibility of AI systems
  • Patient-clinician interaction and relationships
  • The potential dehumanization of healthcare, and loss of physician skills over time
  • Computing resources & storage, and requirements
  • Training data for AI and machine learning systems

Who Will Benefit:

  • Software Engineers
  • Regulatory Professionals
  • Quality Assurance Professionals
  • Marketing
  • Research & Development Engineers

Free Materials:

  • US FDA Artificial Intelligence and Machine Learning Discussion Paper
  • Policy for Device Software Functions and Mobile Medical Applications FDA Guidance
  • FDA Guidance: Clinical Performance Assessment CADe Device
  • Premarket-Cybersecurity-Guidance
  • FDA Guidance: Software as Medical Device - Clinical Evaluation
  • Software as a Medical Device
  • ISO 62304:2015 - Medical device software – Software life cycle processes
  • IMDRF SaMD WG/N10FINAL:2013 – Software as a Medical Device (SaMD): Key Definitions
Instructor Profile:
James W Monroe

James W Monroe
President and CEO, Global RQC Med Device Solutions

Over the past 20 years James has been exclusively involved in the medical device field focusing on Regulatory Affairs and Quality Assurance. Within this arena he has focused on getting medical devices registered globally. His background and track record demonstrates his leadership, from product concept through obsolescence, by (1.) ensuring regulatory compliance, (2.) providing strategic, tactical and operational direction and support for working within the regulations to expedite the development of safe and effective products, (3.) preparing/submitting submissions and managing communications with the Regulatory Bodies, and (4.) keeping up-to-date with changes to the regulatory environment, science and technology, the medical device industry and the healthcare sector through regulatory intelligence.

His regulatory focus is to develop and execute regulatory strategies for client domestically and internationally. He has successful gain multiple 510(k) clearances in the US, and approvals in the EU, Canada, South Korea, and Japan. He is at the forefront of regulatory intelligence staying abreast of the ever-changing medical device requirements globally. His device specialties include but are not limited to: Electro-mechanical and software driven devices, in-vitro diagnostics, digital health (Software as Medical Device, Artificial Intelligence, Machine Learning, Cybersecurity), and Risk Management.

He also holds both a Bachelors and Masters of Electrical Engineering. His Post-Graduate studies were conducted in the Department of Radiology at The Ohio State University where he developed hardware and software applications for the MRI systems and accessories. He has published multiple peer reviewed papers on image processing of medical images for image improvement.

He has held several leadership positions within regulatory and quality including: Director of Regulatory and Clinical at Pharmatech Associates-Medical Devices, Director Regulatory, Pentax Medical, Director of Regulatory & Quality at Immacor Inc., Interim Director at Convatec Inc., Manager of Regulatory at B. Braun Medical. In his role as a consultant he has worked globally with clients as the key regulatory expert responsible for developing regulatory strategies and gaining approval/clearance in multiple countries. He has also served as a 3rd party reviewer for the FDA’s 510(k) program at Intertek.

He has received clearance of over 35 510(k)”s, o f which 90%, involved software. More recently he has focused his regulatory experience in the area of digital health that includes: Software as Medical Device, Artificial Intelligence, Machine Learning, Cybersecurity, and Risk Management. He has also served as a 3rd party reviewer for the FDA’s 510(k) program.

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