№ lp_1_2_23999
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File size: 50 KB
This document outlines the necessary documentation and requirements for an IVD device used in clinical trials, including details on specimen collection, assays, instruments, validation, and participant consent.
Note:
Year
Topic:
Clinical trials, IVD device validation
Document type:
Clinical trial documentation
Target audience:
Regulatory bodies, clinical trial staff, manufacturers
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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
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
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
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
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
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
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.
Year:
2020
Region / City:
Rochester, MN
Topic:
Cybersecurity of medical and research devices
Document type:
Vendor packet
Organization / Institution:
Mayo Clinic
Author:
Mayo Clinic
Target audience:
Vendors, healthcare technology management teams
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2025
Region / city:
EU
Topic:
Health Technology Assessment
Document Type:
Guidance
Organization / Institution:
HTA CG
Author:
European Commission
Target audience:
Professionals in Health Technology Assessment
Validity period:
From 28 NOVEMBER 2025
Approval date:
28 NOVEMBER 2025
Amendment date:
Not specified
Year:
2023
Region / City:
Global
Topic:
Internet of Things, IoT Device Testing
Document Type:
Industry Specification
Organization / Institution:
GSMA
Author:
GSMA
Target Audience:
Mobile Network Operators, IoT Service Providers, IoT Device Makers, IoT Device Application Developers, Communication Module Vendors, Radio Baseband Chipset Vendors
Validity Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Description:
Industry specification document outlining test cases for IoT device compliance with GSMA IoT Device Connection Efficiency Guidelines, focusing on device behavior and network resource management.
Note:
Year
Document type:
Worksheet
Year:
2025
Region / city:
Global
Topic:
Internet of Things (IoT)
Document Type:
Industry Specification
Organization / Institution:
GSM Association
Author:
GSM Association
Target audience:
Mobile Network Operators, IoT Device Manufacturers, IoT Device Application Developers
Period of validity:
Ongoing
Approval date:
May 2025
Date of changes:
Not specified
Year:
2025
Region / City:
United Kingdom
Topic:
COVID-19 treatment, lateral flow device tests
Document Type:
Service Specification
Organization / Institution:
NHS England
Author:
NHS England
Target Audience:
Pharmacy contractors, healthcare professionals
Period of Validity:
Ongoing, from 6 November 2023
Date of Approval:
May 2025
Date of Changes:
01 May 2025
Note:
Year
Subject:
Emergency Use Treatment
Document Type:
Informed Consent Form
HDA Standard Pharmaceutical (Rx-only) Product and Medical Device Information Short Form Instructions
Note:
Year
Theme:
Pharmaceutical products, Medical devices
Document type:
Instructions, Form
Organization / Institution:
HDA
Target audience:
Distributors, Manufacturers, Supply chain professionals
Year:
XXXX
Region / City:
XXX
Theme:
Post-market Surveillance
Document Type:
Report
Organization:
XXX
Author:
XXX
Target Audience:
Regulatory Authorities, Healthcare Professionals
Period of Validity:
[start date] - [end date]
Approval Date:
YYYY-MM-DD
Revision Date:
YYYY-MM-DD
Year:
YYYY
Region / City:
[City/Region]
Topic:
Medical Device Safety and Performance Monitoring
Document Type:
PMCF Plan
Organization:
[Manufacturer Name]
Author:
[Author Name]
Target Audience:
Regulatory Authorities, Medical Device Manufacturers
Validity Period:
YYYY/MM/DD to YYYY/MM/DD
Approval Date:
DD/MM/YYYY
Revision Date:
XXXX
Date of Changes:
YYYY/MM/DD
Year:
2020
Region / city:
Not specified
Theme:
Defense, Technology Development
Document Type:
Statement of Objectives
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Defense contractors, technology developers
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Note:
Year
Subject:
Contraception, Medical Procedure
Document Type:
Patient Information and Consent Form
Target Audience:
Patients, Healthcare Providers