№ lp_1_2_38408
File format: docx
Character count: 17930
File size: 446 KB
This document provides a detailed Post-market Surveillance (PMS) plan in compliance with European Union regulations (MDR 2017/745). It includes information on device status, risk management, and trend analysis related to the listed medical devices.
Year:
XXXX
Region / City:
[City name]
Topic:
Post-market surveillance, medical devices
Document Type:
PMS Plan
Organization / Institution:
[Manufacturer name]
Author:
[Author Name]
Target Audience:
Regulatory bodies, manufacturer representatives
Period of Validity:
DD Month YYYY to DD Month YYYY
Approval Date:
DD Month YYYY
Date of Last Revision:
DD Month YYYY
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Region / City:
Matatiele Local Municipality, Alfred Nzo District
Subject:
Integrated Development Plan, Budget, and Performance Management
Document Type:
Process Plan
Institution:
Matatiele Local Municipality
Author:
Mayor of Matatiele Local Municipality
Target Audience:
Municipal Council, Stakeholders, Local Communities, and Government Institutions
Effective Period:
2026/2027
Approval Date:
To be adopted by the Council
Date of Amendments:
Not specified
Year:
2020/2021
Region/City:
Mkhambathini, Camperdown
Theme:
Integrated Development Planning, Municipal Budgeting
Document Type:
Process Plan
Institution:
Mkhambathini Local Municipality
Author:
Municipal Manager
Target Audience:
Local government stakeholders, municipal employees, community members
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2017
Region / City:
United Kingdom
Document Type:
Formulary Application
Department:
Medicines Committee / Gynaecology
Applicant:
Consultant (name not specified)
Speciality:
Gynaecology
Intended Use:
PMS, postnatal depression, perimenopause in patients with progestogen/progesterone intolerance
Dosage Form:
Vaginal capsules 200mg
Regulatory Status:
Off-label use
Estimated Patient Numbers:
Not specified
Estimated Cost:
£21.00 per 21 vaginal capsules
Supporting Evidence:
Randomised controlled trials and peer-reviewed publications
Approval Required By:
Divisional Medical Director, Lead Directorate Pharmacist
Signatures:
Applicant, Divisional Medical Director, Lead Directorate Pharmacist
Year:
2019
Region / City:
Taipei
Topic:
Religious Service
Document Type:
Homily
Author:
Unspecified
Target Audience:
National Directors of the Pontifical Mission Societies in Asia
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2020
Region / City:
Emalahleni
Subject:
Integrated Development Plan (IDP), Medium Term Expenditure Framework (MTEF)
Document Type:
Notice
Institution:
Emalahleni Municipality
Author:
Municipal Manager Mr VC Makedama
Target Audience:
Interested parties, local residents
Approval Date:
28 August 2020
Period of Effect:
2021/2022, 2021/2023
Amendment Date:
N/A
Contact Information:
Municipal Manager Office, 047 878 2026 / 047 878 2014, [email protected]
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
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:
2021
Region / City:
United States
Topic:
Pharmaceutical and Medical Device Product Information
Document Type:
Instructional Form
Organization / Institution:
Health Distribution Alliance (HDA)
Author:
Health Distribution Alliance
Target Audience:
Pharmaceutical distributors, medical device manufacturers, suppliers
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
2021