Public Inspection: Revocation of Regulations: Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community From Food and Drug Administration (FDA) πΊπΈ Document number 2024-21559. Scheduled to be published on 2024-09-20. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency 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 1 day ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 820 Quality System Regulation From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 820 Quality System Regulation". 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
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
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Guidance document on premarket submissions for cybersecurity in medical devices, providing quality system considerations. 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 26, 2023 Other (Public Domain) 0 reuses 0 favorites
Computer Software Assurance for Production and Quality System Software: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A draft guidance document on computer software assurance for production and quality system software, covering CGMP and postmarket topics. 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 September 12, 2022 Other (Public Domain) 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
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
Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on quality system information for certain premarket application reviews. 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 19, 2020 Other (Public Domain) 0 reuses 0 favorites
On the natural latex rubber condom production quality system special inspection notice From National Medical Products Administration (NMPA) π¨π³ FGWJ-2009-10306 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 August 11, 2009 Other (Public Domain) 0 reuses 0 favorites
Notice of Training Course on Sino-US Medical Device Quality System Regulations and ISO Requirements From National Medical Products Administration (NMPA) π¨π³ FGWJ-2001-10029 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 August 10, 2001 Other (Public Domain) 0 reuses 0 favorites
Quality System Assessment Measures for Medical Device Manufacturing Enterprises (Bureau Decree No. 22) From National Medical Products Administration (NMPA) π¨π³ Decree No. 22 outlines quality system assessment measures for medical device manufacturing enterprises. 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 22, 2000 Other (Public Domain) 0 reuses 0 favorites
Letter on the implementation of medical device quality system certification work From National Medical Products Administration (NMPA) π¨π³ FGWJ-1999-10077 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 28, 1999 Other (Public Domain) 0 reuses 0 favorites