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Character count: 47235
File size: 379 KB
This document is a checklist for assessing compliance with the General Safety and Performance Requirements (GSPR) of the EU Medical Devices Regulation (MDR).
Year:
2017
Region / City:
European Union
Theme:
Medical Devices
Document Type:
Checklist
Organization / Institution:
European Union
Author:
European Commission
Target Audience:
Medical device manufacturers
Period of Validity:
Ongoing
Approval Date:
[Insert Date]
Revision Date:
[Insert Date]
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2022
Region / City:
EU
Topic:
Medical Device Regulation
Document Type:
Technical Documentation
Organization / Institution:
European Union
Author:
Guillaume Valenzuela
Target Audience:
Medical Device Manufacturers
Period of Validity:
Not specified
Approval Date:
19JAN2022
Date of Changes:
Not specified
Context description:
A technical document outlining the General Safety and Performance Requirements (GSPR) checklist for medical devices in compliance with the EU Medical Devices Regulation 2017/745 (MDR).
Year:
2012
Region / City:
Falls Church, VA
Topic:
TRICARE Dental Program, Data Exchange
Document Type:
Interface Control Document (ICD)
Organization / Institution:
DHSS Program Executive Office
Author:
Not specified
Target Audience:
DHSS Program Executive Office, TMA Contract Operations Office
Period of Validity:
Ongoing
Approval Date:
June 7, 2012
Date of Changes:
May 25, 2012
Year:
2004
Region / City:
Falls Church, VA
Topic:
Data Exchange, Health Care Provider Record
Document Type:
Technical Specification
Organization:
EI/DS Program Office
Author:
Mr. Phil Dederer, Mr. Steve Luhrman, Mr. Jeffrey Lopata, Mr. Allen Johnston
Target Audience:
Technical personnel, EI/DS Program Office members, TRICARE Management Activity-Aurora (TMA-Aurora) staff
Effective Period:
Not specified
Approval Date:
May 7, 2004
Revision Date:
Not specified
Year:
2025
Region / City:
European Union
Topic:
Medical Devices
Document Type:
Application Form
Authoring Organization:
Medical Device Coordination Group (MDCG)
Target Audience:
Conformity assessment bodies
Period of Validity:
Ongoing
Approval Date:
January 2025
Amendment Date:
N/A
Year:
2017
Region / City:
European Union
Theme:
Medical Device Regulation
Document Type:
Regulatory Document
Organization / Institution:
Medical Device Coordination Group (MDCG)
Target Audience:
National Authorities, Notified Bodies, Conformity Assessment Bodies
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2017
Region / City:
N/A
Theme:
Medical Device Regulation
Document Type:
Fee List
Organization / Institution:
Notified Body XXXX
Target Audience:
Manufacturers of medical devices
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2010
Region / City:
Falls Church, VA
Subject:
Data Exchange Interface
Document Type:
Interface Control Document
Organization:
DHSS Program Office
Author:
Paul Lindsey
Target Audience:
DHSS personnel, DHIMS personnel
Period of Validity:
Ongoing (until changes made)
Approval Date:
May 10, 2010
Modification Date:
November 23, 2009 (Mod 1)
Description:
This document defines the data exchange process for medical appointments and referrals between the Composite Health Care System (CHCS) and the Military Health System (MHS) Data Repository (MDR).
Document type:
Accountability log
Scope:
Clinical investigation site
Subject matter:
Investigational medical devices
Regulatory framework:
EU Regulation 2017/745 on Medical Devices (MDR)
Applicable date:
26 May 2021
Version date:
18 August 2021
Responsible organization:
Kliniska Studier Sverige
Responsible network:
National network for clinical investigations with medical devices within Clinical Studies Sweden
Geographical context:
Sweden
Intended setting:
Clinical investigation site(s)
Signatory role:
Principal Investigator
Source category:
Clinical research documentation
Year:
2025
Region / City:
European Union
Subject:
Medical Devices
Document Type:
Template
Organization / Institution:
Medical Device Coordination Group (MDCG)
Author:
MDCG
Target Audience:
Conformity Assessment Bodies (CABs), Designating Authorities (DAs), Reviewers
Validity Period:
Not specified
Approval Date:
January 2025
Amendment Date:
Not specified
Year:
2020
Region / city:
East region
Topic:
Health care data management
Document Type:
Technical specification
Organization / Institution:
TRICARE
Author:
N. Bowling
Target audience:
TRICARE contractors, healthcare providers, data analysts
Period of validity:
Ongoing
Approval Date:
12/17/2020
Date of changes:
12/17/2020
Year:
2012
Region / City:
N/A
Subject:
Historical Data Management
Document Type:
Technical Specification
Organization / Institution:
N/A
Author:
D. Sexton
Target Audience:
Developers, Data Managers
Period of Validity:
N/A
Approval Date:
01/07/2012
Date of Changes:
N/A
Year:
2008
Region / City:
Falls Church, VA
Topic:
Case Management Data Exchange
Document Type:
Interface Control Document (ICD)
Organization:
DHSS Program Office
Author:
Paul Lindsey
Target Audience:
DHSS Program Office, BEA, and MHS personnel involved in data exchange
Period of Validity:
Ongoing
Approval Date:
August 18, 2008
Change Date:
N/A
Year:
2016
Region / City:
N/A
Topic:
Data Management / System Integration
Document Type:
Technical Specification
Organization / Institution:
N/A
Author:
T. Comer
Target Audience:
System developers, data administrators
Effective Period:
N/A
Approval Date:
09/27/2016
Revision Date:
N/A
Change History:
Initial versioning
Content:
This document specifies the structure, transmission, and transformation processes for the MTF Location File within the MHS Data Repository (MDR), focusing on linking workload and personnel data from CHCS to MHS Genesis system.
Year:
2012
Region / City:
Falls Church, VA
Topic:
Data Exchange, Military Health System, Contingency Tracking System
Document Type:
Interface Control Document (ICD)
Organization:
DHSS Program Executive Office
Author:
Ms. Karen Hass, Mr. Scott Dreisigacker, Mr. Quinn Smith, Mr. Imran Shah, Mr. Narinder Saund
Target Audience:
DHSS personnel, DMDC staff, Military Health System operators
Period of Validity:
Ongoing, with periodic updates
Approval Date:
April 12, 2012
Revision Date:
None specified
Year:
2012
Region / City:
Falls Church, VA
Theme:
Defense Health Services, Data Management, Health Systems
Document Type:
Interface Control Document (ICD)
Organization:
DHSS Program Executive Office
Author:
Ms. Karen Hass
Target Audience:
DHSS, TMA, MHS Data Management, Health Planning Analysts
Period of Validity:
Not specified
Approval Date:
May 18, 2012
Revision Date:
Not specified
Year:
2025
Region / City:
European Union
Topic:
Medical Devices
Document Type:
Application Form
Authoring Organization:
Medical Device Coordination Group (MDCG)
Target Audience:
Conformity assessment bodies
Period of Validity:
Ongoing
Approval Date:
January 2025
Amendment Date:
N/A
Year:
2017
Region / City:
Madrid, Spain
Topic:
IEEE 11073, HL7 Health Care Devices, PoCD WG
Document Type:
Meeting Agenda
Organization:
IEEE, HL7 International
Author:
ANSI - HL7 International
Target Audience:
IEEE EMBS 11073 SC, PoCD WG, HL7 Health Care Devices WG members
Effective Period:
May 8-11, 2017
Approval Date:
2017-04-27
Date of Last Revision:
2017-04-27
Year:
2023
Region / city:
EU
Topic:
Medical Device Safety
Document Type:
Checklist
Organization:
European Commission
Author:
European Commission
Target Audience:
Medical device manufacturers
Effective Period:
Ongoing
Approval Date:
2023
Revision Date:
Not specified
Year:
2024-2028
Region / city:
Australia
Topic:
ICT policies in schools
Document type:
Procedure/Guideline
Organ / institution:
Department of Education (DoE)
Author:
Department of Education
Target audience:
School employees, students, parents/guardians
Period of validity:
2024-2028
Approval date:
Not specified
Amendment date:
Not specified