Device Ref Model Forum -

Meeting minutes 19.Nov.2015 (No replies)

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