№ files_lp_4_process_3_097683
File format: docx Character count: 18271 File size: 111 KB
Year: 2021
Region / City: USA
Theme: Medical diagnostics
Document type: Technical datasheet
Organization: ZEUS Scientific
Author: ZEUS Scientific
Target audience: Healthcare professionals, laboratory technicians
Period of validity: Not specified
Approval date: Not specified
Date of modifications: Not specified
Context description: A technical datasheet describing the components, precautions, and procedural instructions for the ZEUS IFA EBV-VCA IgM Test System for detecting EBV-VCA IgM antibodies in human sera.
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
EuroImmun protocol for measles IgM
Year: Not specified
Region / city: Not specified
Theme: Measles detection
Document type: Protocol
Organization / institution: EuroImmun
Author: Not specified
Target audience: Laboratory personnel, medical researchers
Period of validity: Not specified
Approval date: Not specified
Date of changes: Not specified
Sample Opening Scenario for Intergovernmental Meeting (IGM) in Hybrid Format via Zoom Webinar — Day 1
Year: Not specified
City: Bangkok
Venue: ESCAP Hall and Virtual Platform (Zoom Webinar)
Organization: United Nations Economic and Social Commission for Asia and the Pacific (ESCAP)
Document Type: Meeting scenario / operational script
Meeting Format: Hybrid (in-person and virtual)
Agenda Scope: Opening session and initial agenda items of an intergovernmental meeting
Main Agenda Items: Opening of the Meeting; Election of Officers; Adoption of Agenda; Secretariat Announcements
Languages Context: Six official languages of the United Nations with remote simultaneous interpretation
Pandemic Context: COVID-19 precautionary measures including mask use in the meeting room
Roles Referenced: Master of Ceremonies, Chair, Outgoing Chair, Secretary, Delegates, Panellists, Conference Room Officer, Technicians
Virtual Platform: Zoom Webinar
Participants: Government delegates, panelists, attendees, and secretariat staff
Procedural Elements: Audio/video testing, interpretation disclaimer, election of bureau, seating arrangement, online speaking procedure
Definition of the Terms “Medical Device” and “In Vitro Diagnostic (IVD) Medical Device”, 2012
Document code: GHTF/SG1/N071:2012
Revision of: GHTF/SG1/N29:2005
Year: 2012
Date: May 16, 2012
Organization: Global Harmonization Task Force
Authoring group: Study Group 1 of the Global Harmonization Task Force
Document type: Guidance document
Subject area: Medical device regulation
Geographical scope: International
Regulatory status: Non-binding guidance
Intended audience: Regulatory authorities, conformity assessment bodies, regulated industry
Supersedes: Definition of the Term “Medical Device”, 2005
Copyright holder: Global Harmonization Task Force
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
Year: 2021
Region / city: International
Subject: In Vitro Diagnostic (IVD) Medical Devices Classification
Document type: Guidance document
Author: IMDRF IVD Working Group
Target audience: Regulatory Authorities, Conformity Assessment Bodies, Industry
Period of validity: Not specified
Approval date: 21 January 2021
Amendment date: Not specified
Copyright holder: International Medical Device Regulators Forum
Copyright year: 2021
IVD Device Clinical Trial Documentation Requirements
Note: Year
Topic: Clinical trials, IVD device validation
Document type: Clinical trial documentation
Target audience: Regulatory bodies, clinical trial staff, manufacturers
Template for an In vitro diagnostic (IVD) medical device Clinical Performance Study Plan (CPSP)
Year: 2024
Region / city: Switzerland
Subject: Clinical performance study for IVD devices
Document type: Template
Organization: swissethics
Author: swissethics
Target audience: Researchers, Sponsors, Ethics Committees
Period of validity: Ongoing
Approval date: 27.06.2022
Modification date: 16.09.2024
Date of changes: 24.06.2025
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
Year: 2018
Region / City: International
Topic: Medical devices, IVD medical devices, safety, performance
Document Type: Guideline
Organization / Institution: International Medical Device Regulators Forum
Author: IMDRF Good Regulatory Review Practices Group
Target Audience: Regulatory Authorities, Conformity Assessment Bodies, manufacturers, industry stakeholders
Effective Period: Not specified
Approval Date: 31 October 2018
Amendment Date: Not specified
Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices
Year: 2012
Region / City: Global
Topic: Clinical Performance Studies for IVD Medical Devices
Document Type: Guidance Document
Organization / Institution: Global Harmonization Task Force (GHTF)
Author: Kazunari Asanuma, GHTF Chair
Target Audience: Manufacturers of IVD medical devices, Regulatory Authorities, Conformity Assessment Bodies
Period of Validity: Ongoing (may apply to both pre-market and post-market studies)
Approval Date: November 2nd, 2012
Date of Revisions: Not specified
Principles of Labeling for Medical Devices and IVD Medical Devices (12 July 2018)
Organization: International Medical Device Regulators Forum
Authoring Group: IMDRF Good Regulatory Review Practices
Document type: Guidance document
Status: Proposed document
Identifier: IMDRF GRRP WG (PD1)/N52
Date: 12 July 2018
Scope: General content and format of labeling for medical devices and IVD medical devices
Applies to: Medical devices and in vitro diagnostic medical devices
Intended audience: Regulatory Authorities, Conformity Assessment Bodies, industry, users and relevant third parties
Supersedes: GHTF/SG1/N70:2011 “Label and Instructions for Use”
Related principles: IMDRF Essential Principles of Safety and Performance
Source type: International regulatory guidance
Topics: EBV-VCA IgM IVD