Informational WHO – Report by the Director-General – Standardization of medical devices nomenclature

12 questions to ask before buying a QMS
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Organizational Chart - Manufacturing Manager report to Director of Quality ISO 13485:2016 - Medical Device Quality Management Systems 1
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 1
S Australia TGA Clinical Evaluation Report (CER) Other Medical Device Regulations World-Wide 0
B Biological evaluation plan and report Other Medical Device Related Standards 5
C 21 CFR 803 malfunction detected during packaging - report? Other US Medical Device Regulations 1
S Management Review (9.3) - Management Review Minutes/Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
dgrainger Informational MDCG 2020:13 - Clinical evaluation assessment report template EU Medical Device Regulations 0
M Sample of Nonconformity report for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Choosing Nonconformities to Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
M OEM asking for NC report after certification audit. IATF 16949 - Automotive Quality Systems Standard 3
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
D Safety Assurance Case Report Format ISO 14971 - Medical Device Risk Management 4
M Risk managment report of Surgical Mask Example ISO 14971 - Medical Device Risk Management 14
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Supplier Audit Report - Template for second party audit wanted Lean in Manufacturing and Service Industries 1
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
G PMS Report - requirements EU Medical Device Regulations 2
F How to fill out an Appearance Approval Report (AAR) APQP and PPAP 0
dinakim_zv CB report or ILAC-MRA report ISO 17025 related Discussions 11
E When to generate a nonconformance report ISO 13485:2016 - Medical Device Quality Management Systems 6
T ISO 27001 sample audit report IEC 27001 - Information Security Management Systems (ISMS) 0
M AS9102 FAI Report formats - Boxes in form 1, 2, 3 of AS9102 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Ajit Basrur Withdrawal of Audit Report Supplier Quality Assurance and other Supplier Issues 3
G Class IIa medical products - PMS report and PSUR EU Medical Device Regulations 6
T Sample of 1st Article Inspection Report wanted APQP and PPAP 3
bryan willemot Looking for a certified test report for aerospace parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
A Recall/Adverse event report procedures in Kuwait/Qatar/Kenya Other Medical Device and Orthopedic Related Topics 3
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M EU – Chemical Safety Report – CSR – REACH Authorisation decisions – Triton X-100 – Ortho-clinical-Use1 REACH and RoHS Conversations 0
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
PhilM Nonconformance report, Customer complaint investigations and RMAs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G Problem Resolution Report Monitoring - Customer complaint or PRR as general motors use Customer Complaints 12
D Clinical Evaluation Report - Consultant Recommendations Consultants and Consulting 9
B More than one Risk Report per Medical Device ISO 14971 - Medical Device Risk Management 3
M Informational Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019 Medical Device and FDA Regulations and Standards News 0
I Functional Safety Analysis/Report Example IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
M Informational US FDA – MDR Data Files – Alternative Summary Report Data Since 1999 Available Medical Device and FDA Regulations and Standards News 0
E CAR (Corrective Action Report) with questionable Root Cause ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
A Medical device CER (clinical evaluation report) training/seminar services EU Medical Device Regulations 2
V Protocol, report or SOP for threshold analysis? Human Factors and Ergonomics in Engineering 0
M Informational Fourth WHO Global Forum on Medical Devices REPORT Medical Device and FDA Regulations and Standards News 0
G Excel report with pictures Excel .xls Spreadsheet Templates and Tools 5
G Measure 3 times, for calibration report? Customer Owned Reference Standard General Measurement Device and Calibration Topics 4
Z In which country is essential to have and IEC 60601 CB Report? Other Medical Device Related Standards 0
G Measuring customer parts on a CMM - How many decimals to report to the customer? ISO 17025 related Discussions 28
R Visually impacting graphics for Nonconformance status metrics for Management Report Nonconformance and Corrective Action 5
H Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER) EU Medical Device Regulations 12
S Medical device CER (clinical evaluation report) according to MDR EU Medical Device Regulations 14

Similar threads

Top Bottom