Quality management and medical devices From Therapeutic Goods Administration (TGA) π¦πΊ Learn about quality management systems and medical devices. 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 June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Learn about quality management systems From Therapeutic Goods Administration (TGA) π¦πΊ Learn about Quality Management Systems and how medical device manufacturers use them to meet their regulatory and customer requirements. 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices; Quality System Regulation Amendments From Food and Drug Administration (FDA) πΊπΈ Document number 2024-01709. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to alignβ¦ 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 2, 2024 Other (Public Domain) 0 reuses 0 favorites
Quality management system audits and certification guidance From Therapeutic Goods Administration (TGA) π¦πΊ Guidance for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification and post-audit activities. 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 December 19, 2023 Other (Non-Commercial) 0 reuses 0 favorites
GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB From Health Sciences Authority (HSA) πΈπ¬ Covers licensing requirements for manufacturers, importers and wholesalers 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 July 1, 2023 Other (Public Domain) 0 reuses 0 favorites
Requirements for Inspections and Quality Management System for Medical Devices (MDS β REQ10) From Saudi Food and Drug Authority (SFDA) πΈπ¦ Regulation outlining requirements for inspections and quality management system for 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 July 28, 2022 Other (Public Domain) 0 reuses 0 favorites
Commission Implementing Decision (EU) 2022/757 of 11Β 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 πͺπΊ 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 11Β 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 πͺπΊ 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
Medical Devices; Quality System Regulation Amendments From Food and Drug Administration (FDA) πΊπΈ Document number 2022-03227. The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices byβ¦ 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 23, 2022 Other (Public Domain) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on the issuance of the territory of the third class of medical devices registered quality management system verification work procedures notice From National Medical Products Administration (NMPA) π¨π³ FGWJ-2022-113 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Commission Implementing Decision (EU) 2022/6 of 4Β January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment From European Parliament πͺπΊ Commission Implementing Decision (EU) 2022/6 amends EU standards for medical devices, sterilization, quality management, and more. 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 January 4, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
GHTF Study Group 3 - Quality Systems From International Medical Device Regulators Forum (IMDRF) π 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
Guidance note integration of the UDI within an organisationβs quality management system From European Commission πͺπΊ This document provides guidance on integrating the Unique Device Identifier (UDI) into an organization's quality management system. 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 Document: Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers From Health Canada π¨π¦ 2010 Health Canada guidance document 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 March 19, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 From Therapeutic Goods Administration (TGA) π¦πΊ Guidance on the two key requirements of the conformity assessment procedures for medical devices that a manufacturer must implement 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 June 19, 2019 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives From Saudi Food and Drug Authority (SFDA) πΈπ¦ QMS requirements for distributors, importers, and authorized representatives 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 May 1, 2019 Other (Public Domain) 0 reuses 0 favorites
Response Letter from the Comprehensive Department of the State Drug Administration on Clarifying Issues Related to the Verification of the Registered Quality Management System of Prefilled Catheter Flushers (Saline) From National Medical Products Administration (NMPA) π¨π³ FGWJ-2020-1591 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 January 15, 2019 Other (Public Domain) 0 reuses 0 favorites
Software as a Medical Device (SaMD): Application of Quality Management System From International Medical Device Regulators Forum (IMDRF) π Technical document: IMDRF/SaMD WG/N23FINAL: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
Notice of the State Food and Drug Administration on the Adjustment of Duties and Responsibilities for the Approval of Changes in Some Medical Devices and the Inspection of Quality Management Systems From National Medical Products Administration (NMPA) π¨π³ FGWJ-2013-10223 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Notice on the high-risk medical device manufacturers quality management system special inspection involving relevant enterprises to deal with the views of the notice From National Medical Products Administration (NMPA) π¨π³ FGWJ-2011-10359 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 November 22, 2011 Other (Public Domain) 0 reuses 0 favorites