21 CFR Chapter I Subchapter H β Medical Devices β Part 822 Postmarket Surveillance From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 822 Postmarket Surveillance". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
DSVG 05 onΒ Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence From European Commission πͺπΊ Document discusses DSVG 05 guidelines on Urogynaecological Surgical Mesh Implants for Pelvic Organ Prolapse and Stress Urinary Incontinence, focusing on Post-Market Surveillance and Vigilance (PMSV). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 27, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
DSVG 04 on Breast implants From European Commission πͺπΊ DSVG 04 on Breast implants: Post-Market Surveillance and Vigilance (PMSV) Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on January 30, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
DSVG 03 on Cardiac implantable electronic devices (CIEDs) From European Commission πͺπΊ This document titled "DSVG 03 on Cardiac implantable electronic devices (CIEDs)" focuses on Post-Market Surveillance and Vigilance (PMSV) for CIEDs. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 30, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
DSVG 02 on Coronary stents From European Commission πͺπΊ This document titled "DSVG 02 on Coronary stents" discusses post-market surveillance and vigilance for coronary stents. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 30, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
DSVG 01 on Cardiac ablation From European Commission πͺπΊ DSVG 01 on Cardiac ablation: A document focusing on Post-Market Surveillance and Vigilance (PMSV) in the context of cardiac ablation. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 30, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Device Specific Vigilance Guidance (DSVG) Template From European Commission πͺπΊ This document is a template for Device Specific Vigilance Guidance (DSVG) and covers topics related to Post-Market Surveillance and Vigilance (PMSV). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 30, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canada From Health Canada π¨π¦ This page includes a notice regarding new regulations strengthening the post-market surveillance and risk management of medical devices in Canada. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 31, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form From International Medical Device Regulators Forum (IMDRF) π (Reclassified from Technical) Information document: IMDRF/NCAR WG/N14 FINAL:2023 (Edition 4) Metadata quality: Metadata quality: Data description empty Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on April 11, 2023 Other (Public Domain) 0 reuses 0 favorites
Requirements for Post-Market Surveillance of Medical Devices (MDS β REQ11) From Saudi Food and Drug Authority (SFDA) πΈπ¦ Regulation outlining requirements for post-market surveillance of medical devices. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on March 28, 2023 Other (Public Domain) 0 reuses 0 favorites
Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices From European Commission πͺπΊ This document provides an overview of vigilance terms and concepts in the EU regulation on medical devices, focusing on post-market surveillance. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 From European Commission πͺπΊ Get guidance on Periodic Safety Update Reports (PSUR) as per EU Regulation (EU) 2017/745, covering Post-Market Surveillance and Vigilance (PMSV). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Guidance document providing information on postmarket surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 17, 2022 Other (Public Domain) 0 reuses 0 favorites
Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements - Guidance for Industry and for FDA Reviewers/Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on testing metallic plasma sprayed coatings on orthopedic implants for postmarket surveillance requirements. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 18, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for manufacturers and FDA staff on adverse event reporting and postmarket surveillance for medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 9, 2019 Other (Public Domain) 0 reuses 0 favorites
Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan From International Medical Device Regulators Forum (IMDRF) π Information document IMDRF/NCAR WG/N30FINAL:2015. Metadata quality: Metadata quality: Data description empty Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on October 2, 2015 Other (Public Domain) 0 reuses 0 favorites
Postmarket Surveillance From Food and Drug Administration (FDA) πΊπΈ Document number 00-21827. The Food and Drug Administration (FDA) is proposing to implement the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the FDA Modernization Act of 1997 (FDAMA). The purpose of this proposed rule is to provide forβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 29, 2000 Other (Public Domain) 0 reuses 0 favorites