SBS - The best value in QMS software

Medical Device Reporting SOP (Standard operating procedure) example

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Medical device incident reporting (MDIR) guide Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Statement on agency’s efforts to increase transparency in medical device reporting Medical Device and FDA Regulations and Standards News 0
A Japan's Requirements for Reporting Medical Device Adverse Events Other Medical Device Regulations World-Wide 2
M Informational TGA – Medical device annual reporting – Sponsor obligations Medical Device and FDA Regulations and Standards News 0
shimonv Reporting Medical Device Changes with Annex V/VII EU Medical Device Regulations 1
L MDR (Medical Device Reporting) under 21 CFR Part 803 Other US Medical Device Regulations 5
Q Medical Device Reporting In US/ EU/ Canada Customer Complaints 6
N Notification of Changes to a Class I Medical Device - Reporting Requirements EU Medical Device Regulations 4
A What are the obligatory medical device reporting timelines for AIMD devices ? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Is there a MDR (Medical Device Reporting) equivalent in China ? China Medical Device Regulations 1
A 21 CFR Part 803 (Medical Device Reporting) and Public Health US Food and Drug Administration (FDA) 2
Q Reporting Significant Medical Device Changes to Argentina's ANMAT Other Medical Device Regulations World-Wide 3
S Help with EU Medical Device Vigilance Reporting Requirements EU Medical Device Regulations 0
M Weblinks in Medical Device Reporting Procedures ISO 13485:2016 - Medical Device Quality Management Systems 9
S FDA Warning Letter on Medical Device Reporting Interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
R Role of Contract Manufacturer - MDRs (Medical Device Reporting) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
L Medical Device Reporting vs Recall/Correction: What action to take? US Food and Drug Administration (FDA) 5
S FDA terms - Adverse Events, Medical Device Reporting, MAUDE and Customer Complaints US Food and Drug Administration (FDA) 1
N Exclusion of Medical Device Reporting of Components for Medical Systems ISO 13485:2016 - Medical Device Quality Management Systems 4
T Reporting changes to a Class II Medical Device in Canada Canada Medical Device Regulations 3
G FDA MAUDE Medical Device Reporting Database Analytics US Food and Drug Administration (FDA) 6
D Malfunctions, 2 year History, and Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Flowchart to explain the Medical Device Vigilance Reporting Process wanted EU Medical Device Regulations 4
T EU Medical Device Vigilance Reporting Requirements EU Medical Device Regulations 3
S MDR (Medical Device Reporting) Justification - Canned Statements Other US Medical Device Regulations 2
T Medical Device Reporting Procedure ISO 13485:2016 - Medical Device Quality Management Systems 2
E Taiwan Medical Device Adverse Event Reporting Other Medical Device Regulations World-Wide 6
C Medical Device Reporting Procedures compliant with FDA and CE Marking Requirements EU Medical Device Regulations 7
T US FDA Medical Device Reporting SOP help 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
L Interpretation of MDR Reportable Event - FDA guidance on Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
B Medical Device Vigilance Reporting Multi Markets Other ISO and International Standards and European Regulations 2
M Who regulates Medical Device? Global Medical Device Reporting Process Other Medical Device and Orthopedic Related Topics 6
bio_subbu OIG Reports on Medical Device Adverse Event Reporting system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C Medical Device Reporting procedure - Correction and Removal (21 CFR 806) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Draft Guidance: eMDR - Electronic Medical Device Reporting (Updated) US Food and Drug Administration (FDA) 3
Q When to File an MDR (Medical Device Reporting) For Incidents in Foreign Countries 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
O Medical Device Reporting - MDRs for incidences outside the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Canadian Medical Device Reg -- Mandatory Reporting? Various Other Specifications, Standards, and related Requirements 1
M (medical device) V&V phase: justification of acceptance criteria (statistical method ?) Design and Development of Products and Processes 0
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 1
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
M Medical device substance based-leachables Other Medical Device Related Standards 1
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1

Similar threads

Top Bottom