AI-Based Medical Device Regulatory Guidelines
Explore the updated DEL02.2 guidelines for AI-based medical devices' regulatory requirements. This presentation covers the scope, checklist for compliance verification, and target audience involved in the development and regulation of AI in healthcare technology.
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Presentation Transcript
FGAI4H-I-036-A01 E-meeting, 7-8 May 2020 Source: Editors Title: Updated DEL02.2: Guidelines for AI based medical device: Regulatory requirements (Draft: April 2020) - Att.1: Presentation Discussion Luis Oala HHI Fraunhofer, Germany Christian Johner Johner Institute for Healthcare IT, Germany Pradeep Balachandran E-health expert, India This PPT contains a presentation of I-036, Updated DEL02.2: Guidelines for AI based medical device: Regulatory requirements. Purpose: Email: luis.oala@hhi.fraunhofer.de Contact: Email: christian.johner@johner-institut.de Contact: Email: pbn.tvm@gmail.com Contact: Abstract: NOTE This presentation has been recreated from screenshots of the original presentation online, hence the reduced resolution in some slides.
AI4H Guideline From Regulations to Application By Pradeep Balachandran, Luis Oala, Sven Piechottka, and Christian Johner
Target Audience Developers, Data Scientists Requlatory Affairs Quality Managers (Medical Professionals) NotifiedBodies Authorities
Proposed Scope of AI4H Scope of IEC 82304 Software as Medical Device Scope of AI4H Guideline Software is product == Scope of IEC 62304 Software is part of product No medical device (but application in healthcare) Medical Device no enforcement Medical Device with enforcement
Target Checklist for Verification of Compliance with Requirements Requirements specific for Medical Applications Regulatory Requirements (mostly AI unspecific)
Target Structure Requirement Checklist Item Example, Comment Reference Priority
