Next Devices Subgroup Call - 9.Apr.2015, 17:00 CEST / 11am et (3 replies)
Current list of invitees (please let me know if if corrections are required)
Meeting minutes attached
| Meeting Purpose | DIA EDM Reference Model - Devices | ||
| Meeting Date | 09.04.2015 | ||
| Meeting Time | 17:00 (CET) - Europe Time (Rome, GMT+01:00) | ||
| Meeting Location | Webex | ||
| Meeting Facilitator | Metod Ostanek in absence of Romuald Braun | ||
| Meeting Attendees | Company | Name | |
| Infotehna | Romuald Braun | ||
| Eric Haase ??? | |||
| Metod Ostanek | |||
| Renato Rjavec | |||
| David Gwyn | |||
| Brooke Cesselberry | |||
| Cheryl Lewis | |||
| Jan Stepanek | |||
| Michael ???? | |||
| Valeant | Romuald Urbansi | ||
| SteveScribner | |||
| Yong Liu | |||
| Discussions and Action Items | ||||
| # | Topic Discussed | Discussion & Required Action (if any) |
Assigned To | Due Date |
| 01 | Introduction and short background information on EDM Submission Reference Model and the purpose of the Medical Device Team | D. Gwyn | ||
| 02 | Web site for communication and exchange – https://edmrefmodel.com/device-reference-model-team/ | Established (R. Braun) | ||
| 03 | Devices reference Model – Starting point | presented (xls and format in MindJet) | M. Ostanek | |
| 04 | Terminology used in Reference Mode | Suggestion to introduce additional column(s) for definition of terms – to standardise and to have common understanding. | ||
| 04a | Consider differentiation for Clinical & Non-Clinical documents | |||
| 05 | Structure – Submission oriented vs Subject oriented structure | Submission structure is the basis for the submission. For work on Reference Model attributes the Subject structure is probably more appropriate. | ||
| 06 | STED Structure vs RPS Structure | Check the STED structure provided by RomualdUrbanski | M. Ostanek | |
| 06a | Compare the STED structure against RPS structure. | |||
| 07 | How to improve the visibility of the team and the initiative. | Get a feedback from previous meeting. | all | ongoing |
| Spread the info around – list of potential members/ contributors | all | ongoing | ||
References for RM:
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-n063-2011-summary-technical-documentation-ivd-safety-conformity-110317.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
RPS – Authoring Group:Regulated Product Submissions Table of Contents Working Group, 2014
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140630-rps-nivd-toc.pdf
- 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-ivd-toc.pdf
- In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
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