Identification of Russian Predicate Devices as part of the Registration Process

R

RA Princess

Could anyone point me in the direction of the best way to identify predicate Russian devices as part of the registration process?

Many thanks
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G Clause 8.5.1 -- Is non Identification evidence of ineffective control of production ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
M ISO 13485:2016 Identification & Traceability ISO 13485:2016 - Medical Device Quality Management Systems 4
T Use errors identification - based on primary operating functions or use scenarios ? IEC 62366 - Medical Device Usability Engineering 3
M Document Control - Applying Suitable Identification to Obsolete Documents ISO 13485:2016 - Medical Device Quality Management Systems 7
H Resin Identification Code Applicability REACH and RoHS Conversations 1
H Marking of Resin Identification Code CE Marking (Conformité Européene) / CB Scheme 0
C Document Identification Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R IRB Identification US Food and Drug Administration (FDA) 0
J Help needed on clauses identification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Y CE marking with NB identification number EU Medical Device Regulations 0
Q ISO 20417:2021- Regulatory Identification Other ISO and International Standards and European Regulations 3
R UDI Number Identification EU Medical Device Regulations 5
K Identification test in ph.eur. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
S SOP Identification of Special Characteristics IATF 16949 - Automotive Quality Systems Standard 9
I Hazard Identification and Naming ISO 14971 - Medical Device Risk Management 10
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Identification of hazards and Risk file IEC 62366 - Medical Device Usability Engineering 15
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
T Non conformance product identification and traceability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
qualprod Monitoring of lead time - Good KPI identification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
qualprod Controlled sticker for product identification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Watchcat Identification of Test Sample in Test Reports? Design and Development of Products and Processes 22
B Marking of Medical Electrical equipment and accessories - Cl. 7.2.2 "Identification" and Cl. 7.2.4 "Accessories" IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
Z Two Payment Identification Number (PIN) for the same order in DFUF website 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Identification and Traceability with an ERP system - Barcode Labels? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture. EU Medical Device Regulations 1
M Informational USFDA final guidance – Unique Device Identification: Convenience Kits Medical Device and FDA Regulations and Standards News 0
Stefan Mundt ISO 9001:2015 - 8.5.2 Identification and Traceability Manufacturing and Related Processes 14
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S UDI (Unique Device Identification) Requirements for Remanufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Quality Management System documentation identification Document Control Systems, Procedures, Forms and Templates 11
K Document Numbering (Identification) System Document Control Systems, Procedures, Forms and Templates 10
N Requirements for the identification and traceability of demo product for sales force US Food and Drug Administration (FDA) 1
M RFID (Radio Frequency Identification) Registration in Europe and in MENA countries EU Medical Device Regulations 1
qualprod Identification of Training Needs = People Performance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
H European Pharmacopoeia First Identification Requirements Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Q Identification of gage blocks General Measurement Device and Calibration Topics 8
DeeDeeM IATF16949, clause 8.5.2.1 Identification and traceability-supplemental IATF 16949 - Automotive Quality Systems Standard 1
DeeDeeM IATF 16949 - Clause 8.5.2 Identification and Traceability IATF 16949 - Automotive Quality Systems Standard 7
Q ISO 9001 Cl. 8.5.2 and 8.5.4 - Identification in Products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Measurement Equipment - Identification of Calibration Status General Measurement Device and Calibration Topics 25
J Customer Identification and Traceability in Manufacturing Plans Manufacturing and Related Processes 5
M Risk Identification and Risk Assessment for any Process - Is it necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
Edward Reesor UDI (Unique Device Identification): HIBCC or GS1? ISO 13485:2016 - Medical Device Quality Management Systems 39
R Identification of Medical Devices in MDD 93/42 Certificate EU Medical Device Regulations 2
L Managing Finance Processes - Identification of Sub Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom