Meeting Minutes - 21.May.2015 - Device Ref Model Forum - Submission Reference ModelSubmission Reference Model

Meeting Minutes - 21.May.2015 (1 reply and 1 comment)

9 years ago

Romuald 9 years ago

Meeting Purpose	DIA EDM Reference Model - Devices
Meeting Date	21.05.2015
Meeting Time	17:00 (CET) - Europe Time (Rome, GMT+01:00)
Meeting Location	Webex
Meeting Facilitator	Romuald Braun
Meeting Attendees	Company	Name
	Infotehna a euroscript company	Metod Ostanek
	TEVA / PLIVA	Marija Uglesic
	Impact Systems	Cheryl Lewis
	VRS	Bruce Salkovitz
	Valeant	Jan Stepanek
	Fresenius Kabi	Yong Liu
	Maia Consulting	Dimitri Stamadiatis
	Genzyme	Michael Jasper
	Valeant	Romuald Urbanski
	Bausch & Lomb	Antje Nestler	part

Discussions and Action Items
#	Topic Discussed	Discussion & Required Action (if any)	Assigned To	Due Date
00	Review of minutes and open topics from previous meeting	Reminder – this is voluntary work on top of your daily commitments. Any support would be appreciated and individual assignment will be appreciated	All	Done
01	STED Structure vs RPS Structure	(see previous minutes from 07.May.2015)		Done
02	Devices reference Model	(see previous minutes from 07.May.2015)		Done
		Decision confirmed to continue with the RPS based model, while keeping cross-reference with STED and 510k	All	Done
02a		STED vs US 510k mappingYong explained his approach and conclusions: STED has higher granularity than 510k	Yong	Done
02a.a		RPS vs. US 510k mapping	Yong	Ongoing
02b		Sheet - RPS_RM_Sort by Group should be break-down to individual xls sheets per Domain.Current Domains:•Regulatory/Admin, •Prescribing Information /Labeling, •CMC /Technical/Quality & Mnf/ •Clinical (includes also non-clinical attributes)	Broke	Ongoing
02c		Proposed artifact names shold be unique regardless of its position within the model in order to avoid confusion. Check for duplicates should be performed.	All	Future
02d		Proposed artifact names should be checked in the context of the authoring process. In case artifacts are in reality authored as serveral sub-artifacts and later compiled together, another level of sub-artifacts should be introduced to cover this scenario.	All	Future
03	Metadata matrix	Metadata mapping should be checked	All	Future
04	Terminology used in Reference Mode	Suggestion to introduce additional column(s) for definition of terms – to standardise and to have common understanding.		Ongoing
		Decision was made to use the Excel format as leading format and if required upload to the MindMap tool (eg. For visualization)	All	Done
04a		Try to add additional columns and assess/discuss the complexity with the team	Metod	Ongoing
		Consider differentiation for Clinical & Non-Clinical documents		Future
05	How to improve the visibility of the team and the initiative.	Spread the info around – list of potential members / contributors	All	Ongoing
05a		Approach medical devices forums and associations to test their motivation to join the Ref.Model initiative:-IMDRF-ADVAMED -MEDTECHEUROPE (See links below)	Romuald B.In progress	Ongoing
06	Webex – technical issue with voice quality	dial-in option should be investigated	Romuald B.	Ongoing
07	Structure mapping between RPS nIVD and STED nIVD (TAB07)	Review the current mapping between RPS and STED (TAB 07)	Romuald U.	Ongoing
08	Consider IDMRF Consultations and Documents	Especially - Regulated Product Submission - Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions (http://imdrf.org/consultations/cons-rps-atg-imdrf-toc-150409.asp )		Future

DIA EDM Reference Model – Devices: general info & References for RM:

Web site for communication and exchange – https://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

International Medical Device Regulators Forum

http://imdrf.org/index.asp

Advanced Medical Technology Association

http://advamed.org

MedTech Europe