SBS - The best value in QMS software

Medical Device Clinical Evaluation Standard Operating Procedure / SOP

sherley13

Involved In Discussions
#1
Dear All,

Recent ISO 13485 Auditors has been asking for Post Market Surveillance procedure ( SOP)/for Medical devices if you have anyone please share with us.

Thank you.

sherley 13
 
Elsmar Forum Sponsor
S

Shamann2

#5
Thank you. I am now able to see the attachments. I think the updated links were needed.
 
L

LIZ IM

#8
Hello~
I looked at both of these posts repeatedly and I don't see any attachment. please let me know updated link.
 
Thread starter Similar threads Forum Replies Date
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
R Do Medical Device Complaints include Clinical Trials? Medical Device and FDA Regulations and Standards News 3
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
T Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial Other US Medical Device Regulations 9
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
M Custom Medical Device For Clinical Study Other Medical Device Regulations World-Wide 1
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 5
A Medical device CER (clinical evaluation report) training/seminar services EU Medical Device Regulations 2
T Medical device Clinical trial exemption list China Medical Device Regulations 2
S Medical device CER (clinical evaluation report) according to MDR EU Medical Device Regulations 24
S Clinical evaluation for a class IIa medical device - EU MDR Requirements EU Medical Device Regulations 3
I FDA Class II Medical Device Clinical Trials and and FDA IDE Requirements US Food and Drug Administration (FDA) 3
MDD_QNA Clinical data requirements - Changing a Class I Medical Device to Class II EU Medical Device Regulations 5
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Imported Legacy Blogs 1
M Does Medical Device Usability Study = Clinical Trial? Other Medical Device and Orthopedic Related Topics 26
bio_subbu USFDA issues draft Guidance on the Acceptance of Medical Device Clinical Data Other US Medical Device Regulations 1
E Number of medical device clinical trials has reduced by 20% in Korea Other Medical Device Regulations World-Wide 1
R FDA's guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studies Other US Medical Device Regulations 3
M Category I Medical Device Clinical Data Requirements EU Medical Device Regulations 3
E Medical Device Class 2a CE Mark Clinical Evaluation Report CE Marking (Conformité Européene) / CB Scheme 3
K Medical Device Design Validation vs Clinical Evaluation ISO 13485:2016 - Medical Device Quality Management Systems 5
S Clinical or Non-Clinical Data in 510(k) Submission for a type II Medical Device US Food and Drug Administration (FDA) 1
I Medical Device Clinical Trial Audit Checklist wanted ISO 13485:2016 - Medical Device Quality Management Systems 2
A Application for Medical Device Clinical Studies in Belgium CE Marking (Conformité Européene) / CB Scheme 2
F Medical Device Clinical Evaluations - How often are Clinical Evaluations required? EU Medical Device Regulations 2
M Medical Device Website Document Control - Clinical Advice or Performance Claims Document Control Systems, Procedures, Forms and Templates 2
P Medical Device Clinical Trial Labels Other Medical Device and Orthopedic Related Topics 3
C Medical Device: QSR and Clinical Trials and Design Controls ISO 13485:2016 - Medical Device Quality Management Systems 3
B Medical Device Directive 93/42 EEC - Clinical Trials - Because the auditor says so? ISO 13485:2016 - Medical Device Quality Management Systems 18
M Verification Activities - Clinical Medical device manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 0
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
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 2
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom