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:
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
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices, March 17th, 2011
(if any)