Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on the use of ISO 10993-1 for evaluating and testing medical devices within a risk management process. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Australia’s breast implant risk management framework From Therapeutic Goods Administration (TGA) 🇦🇺 This framework outlines our processes to identify and manage risk relating to breast implants. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on May 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
MU103_10_001e_WL Guidance document RMP / ICH E2E – Information for submission of RMP HMP From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document provides guidance on the submission of Risk Management Plans (RMP) and Health Management Plans (HMP) for regulatory purposes. 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 November 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canada From Health Canada 🇨🇦 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
Commission Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2022/757 amends Implementing Decision (EU) 2021/1182 on harmonised standards for quality management systems and risk management in medical devices. 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 May 11, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2022/729 amends EU Implementing Decision (EU) 2021/1195 on harmonised standards for quality management systems and risk management in medical devices. 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 May 11, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
GHTF Study Group 3 - Quality Systems From International Medical Device Regulators Forum (IMDRF) 🌍 GHTF Study Group 3 - Quality Systems documents 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 November 2, 2012 Other (Public Domain) 0 reuses 0 favorites
The TGA's risk management approach From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance outlines the broad approach adopted by the TGA to identify and manage risk associated with therapeutic goods 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 February 24, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Statement regarding Use of ISO 14971:2007 "Medical devices - Application of risk management to medical devices" From International Medical Device Regulators Forum (IMDRF) 🌍 Information document IMDRF/MC/N34 FINAL: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
Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" From International Medical Device Regulators Forum (IMDRF) 🌍 Information document IMDRF/MC/N37 FINAL: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
About the work of the TGA - a risk management approach From Therapeutic Goods Administration (TGA) 🇦🇺 Whether applying a bandage, relieving a headache with items from the supermarket or undertaking a prescribed course of treatment to manage a serious illness, Australians can expect the medicines and medical devices they use to meet an acceptable level of safety and quality. 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 15, 2011 Other (Non-Commercial) 0 reuses 0 favorites
ARGB Appendix 11 - Risk management From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance outlining the approach that should be taken to risk management as applicable to biologicals. 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 July 14, 2011 Other (Non-Commercial) 0 reuses 0 favorites