Medical Device Single Audit Program (MDSAP) From Therapeutic Goods Administration (TGA) 🇦🇺 The MDSAP allows recognised organisations to audit device manufacturers in a single program that satisfies the requirements of the participating regulatory authorities. 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 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Frequently asked questions for the Medical Device Single Audit Program (MDSAP) From Therapeutic Goods Administration (TGA) 🇦🇺 Read our questions and answers for sponsors and manufacturers about the Medical Device Single Audit Program (MDSAP). 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 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/MDSAP WG/N11FINAL:2014 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 20, 2021 Other (Public Domain) 0 reuses 0 favorites
Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) From European Commission 🇪🇺 This document provides guidance for notified bodies on using MDSAP audit reports during surveillance audits under MDR/IVDR. 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
Resolution - RE No. 392 of 20/02/2018 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Recognizes the Medical Device Single Audit Program (MDSAP), to subsidize health inspection and surveillance actions. Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on April 21, 2020 Other (Public Domain) 0 reuses 0 favorites
Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes From International Medical Device Regulators Forum (IMDRF) 🌍 Information document IMDRF/MDSAP WG/N29FINAL: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
MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes From International Medical Device Regulators Forum (IMDRF) 🌍 Information document IMDRF/MDSAP WG/N22FINAL:2014. 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 September 18, 2014 Other (Public Domain) 0 reuses 0 favorites