Indications for Use - Is it possible to have a different indication for use

Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Y Expanding the indications for use for a 510(k) cleared device Medical Device and FDA Regulations and Standards News 5
P Predicate Device Indications for Use US Food and Drug Administration (FDA) 1
K Intended Use-Class I Self Certified - Intended Use and Indications for Use statements EU Medical Device Regulations 1
J One Medical Device, two indications, two classes, one technical file? EU Medical Device Regulations 3
A Inform NB of change to Indications of Use, but change is not a medical feature CE Marking (Conformité Européene) / CB Scheme 1
C Legal requirement for same indications as in Country of Origin Other Medical Device Regulations World-Wide 4
F Marketing a single medical device with multiple indications Other US Medical Device Regulations 4
R New 510k requirements for Change in Indications for Use 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L IEC 60601-2-54 problem with Dosimetric Indications IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C Indications for Use vs. Intended Use in User Manual 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
R OEM part number is listed in the Indications for Use Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T "Indication for Use" used in 510(k) - Indications for Use vs. Intended Use ISO 13485:2016 - Medical Device Quality Management Systems 7
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
M Informational EU – Possible EUDAMED delay Medical Device and FDA Regulations and Standards News 3
M Is it possible to get iso 13485:2016 certified as a one man band ISO 13485:2016 - Medical Device Quality Management Systems 1
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
dhuot1990 USP 41 Hanging Scale - Is it possible to make a hang scale adhere to USP41 Standards? ISO 17025 related Discussions 3
F Apple Watch is not a medical device. How can this be possible? CE Marking (Conformité Européene) / CB Scheme 1
qualprod ISO 9001:2015 Clause 8.3 - Is it possible to exclude one product but include it in other? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Ashok sunder Is it possible to reduce FMEA Occurrence and Detection Ranking after corrective action taken for customer complaints? FMEA and Control Plans 6
B Integrated management system - ISO 9001 and ISO 14001 - Is possible to have a joint certificate covering both standards? ISO 14001:2015 Specific Discussions 6
E Is it possible to start an ISO 9001 QMS from scratch (Really) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Some possible misunderstandings on the application of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
P Is it possible to make an educated decision using a very very small sample size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
a_bardi Is it possible to exclude internal audit from qms scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G ISO 9001:2015 - Is control possible with Excel adaptable measurement sheets? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
C %GRR <10% not possible. How to get approval by auditor? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
M Is Automated Internal Auditing Possible? Internal Auditing 13
A Integrated Management Systems - ISO 50001 and ISO 9001 possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Is it possible to receive EASA STC within 48 hours after modification? EASA and JAA Aviation Standards and Requirements 1
3 Israel: 1 Medical Device, Multiple Registrations = Possible? Other Medical Device Regulations World-Wide 3
Marc Yahoo probes possible huge data breach - BBC News - 2016 World News 1
Marc Yahoo probes possible huge data breach World News 0
S Preparing a Root Cause Report - Possible Root Causes Document Control Systems, Procedures, Forms and Templates 11
M Future of ISO 14971 - Possible revision? ISO 14971 - Medical Device Risk Management 9
M Is IEC 60601 compliance possible when only generic power-supply is specified? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Is it possible to have more than one authorized representative in Saudi Arabia? Other Medical Device Regulations World-Wide 6
Y Is it possible to check the authenticity of a CFDA registration certificate? China Medical Device Regulations 7
T Reduced Audit days when UPGRADING from AS9100 to TS16949 - Is it possible? IATF 16949 - Automotive Quality Systems Standard 2
Ajit Basrur Is Biocompatibility study performed on medical devices for possible contaminants? Other Medical Device Related Standards 4
B Subsidiary - No Managing Director - Is ISO 9001 Certification Possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Is it possible to randomly select samples from 1 column to many column Using Minitab Software 2
Marc Google Fiber chooses nine metro areas for possible expansion After Work and Weekend Discussion Topics 1
Hershal ILAC is preparing to start the possible revision to ISO/IEC 17025 ISO 17025 related Discussions 2
0 Is it possible to use a threaded ring gage to calibrate the M8 gage? Calibration and Metrology Software and Hardware 4
A Is it possible for STC application before issue of TC ? EASA and JAA Aviation Standards and Requirements 4
B Is it possible that a virus sends spam on Facebook? After Work and Weekend Discussion Topics 6
Ronen E Incretin Mimetic Drugs for Type 2 Diabetes: Possible Increased Risk Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0

Similar threads

Top Bottom