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FDA Guidance on Reprocessing Medical Devices: Validation of Cleaning
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1121578
Time Stamp: Oct 4, 2021
TGA Guidance on Requirements for COVID-related IVDs
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1121580
Time Stamp: Oct 4, 2021
FDA Guidance on Design Validation
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1121582
Time Stamp: Oct 1, 2021
Health Canada Guidance on Investigation of Reported Medical Device Problems: Risk Evaluation and Control
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1121584
Time Stamp: Sep 30, 2021
FDA on Content of Premarket Submissions For Medical Device Software: Documents in Detail
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1875292
Time Stamp: Sep 20, 2021
MDCG Guidance on Certification Activities
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1867045
Time Stamp: Sep 17, 2021
FDA Guidance on Recall Strategy: Development and Execution
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1019246
Time Stamp: Aug 13, 2021
EMA Guidance on Documentation for Medicines in Medical Devices
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1019248
Time Stamp: Aug 12, 2021
FDA Guidance on Design Control: Design Input
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1861121
Time Stamp: Aug 12, 2021
HSA Consultation on Risk Classification of Standalone Medical Mobile Applications (SaMD)
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1019256
Time Stamp: Aug 11, 2021
MDCG Explanatory Note on IVDR Codes
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1019259
Time Stamp: Aug 11, 2021
FDA on Software Changes: Additional Factors
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1019422
Time Stamp: Aug 10, 2021
FDA Policy on Software Functions
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1019426
Time Stamp: Aug 10, 2021
FDA Guidance on Labeling for In Vitro Diagnostic Devices
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1019428
Time Stamp: Aug 9, 2021
FDA Guidance on Infusion Pumps: Overview
Source Cluster:
RegDesk Blog | RegDesk Source Node: 997045
Time Stamp: Aug 1, 2021
MDCG Joint Implementation Plan for IVDR
Source Cluster:
RegDesk Blog | RegDesk Source Node: 997047
Time Stamp: Aug 1, 2021
FDA Guidance on General Device Labeling
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1859125
Time Stamp: Jul 30, 2021
Health Canada Q&A on License Application Types
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1859115
Time Stamp: Jul 30, 2021
FDA on Electronic Source Data in Clinical Investigations
Source Cluster:
RegDesk Blog | RegDesk Source Node: 1859009
Time Stamp: Jul 29, 2021