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Meeting minutes 19.Nov.2015 (No replies)

Romuald
3 years ago
Romuald 3 years ago
Meeting Purpose DIA EDM Reference Model - Devices
Meeting Date 19.Nov.2015
Meeting Time 16:00 (CET) - Europe Time (Rome, GMT+01:00)
Meeting Location Webex
Meeting Facilitator Romuald Braun
Meeting Attendees Company Name
Merz Pharma (DE) Christine
Paragon Ty (T. Molchany ?)
Scribner Group Steve Scribner
Infotehna Eric Haase
Qdossier Hans van Brugen
Discussions and Action Items
# Topic Discussed Discussion & Required Action
(if any)
Assigned To Due Date
01 Please refer to minutes from last call from 05.Nov.2015
02 Definition of terms In context of a very slow progress of definition of terms, the meeting was focusing on ideas on how to extend the circle of participants and increase the motivation to contribute. In addition, ideas related to: where could we source the definitions from, were discussed. Below list of ideas and actions:
02a Try to include RAPS members/participants
-Contact RAPS to generate a link Eric
-Approach Antoinette to understand her recent contribution Romuald
-Utilize IDMP (ISO) standards for some definitions
-Utilize UDI for some definitions
-Approach chairs of other Reference Model Groups Romuald
-Analyse LinkedIn groups
-Add goals and objectives to Devices WebPage Romuald
-Extend name from DIA Reference Model to DIA/RAPS Reference Model
DIA EDM Reference Model – Devices: general info & References for RM:
Web site for communication and exchange – http://edmrefmodel.com/device-reference-model-team/
STED – Authoring Group: Study Group 1 of the Global Harmonization Task Force
Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED), February 21, 2008
http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n011-2008-principles-safety-performance-medical-devices-080221.pdf
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices, March 17th, 2011
http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n063-2011-summary-technical-documentation-ivd-safety-conformity-110317.pdf
RPS – Authoring Group: Regulated Product Submissions Table of Contents Working Group, 2014
Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC)
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140630-rps-nivd-toc.pdf
In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140630-rps-ivd-toc.pdf
Medical Devices Forums and Associations
IMDRF - International Medical Device Regulators Forum
http://imdrf.org/index.asp
Advanced Medical Technology Association
http://advamed.org
MedTech Europe
http://www.medtecheurope.org