SBS - The Best Value in QMS software

Publication of user information in manufacturer website for medical devices

Ramya

Starting to get Involved
#1
Hi,

Is there any regulatory requirement which says that publication of user information like IFU mandated on the medical device manufacturer's website?
 
Elsmar Forum Sponsor

Ramya

Starting to get Involved
#3
Thanks for the prompt response.
Kindly let me know if there are any regulations except MDR which calls for this?
 
Thread starter Similar threads Forum Replies Date
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
T Misbranding (by someone we've contracted with) in a Publication 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
Claes Gefvenberg Publication of ISO 45001 - Occupational Health and Safety - Further delays? Occupational Health & Safety Management Standards 6
R ISO 80369-7 Publication Date - 10/14/2016 Other Medical Device Related Standards 7
K May 16 2014 Official Journal of the European Union Publication - 60601-2-33 EU Medical Device Regulations 3
A Publication Dates of MSA Manuals (1st & 2nd Ed.) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
J AS9104-003 Publication Date AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
P ISO/TS 16949:2009 Status - Anybody know the target publication date IATF 16949 - Automotive Quality Systems Standard 71
Stijloor New AIAG Publication Alert: Pandemic Preparedness & Response Plan World News 13
S Authors Needed for "The Auditor," a new bimonthly publication General Auditing Discussions 11
Sidney Vianna The Auditor - A new Publication General Auditing Discussions 9
Y Target Magazine - A publication of the Association for Manufacturing Excellence Statistical Analysis Tools, Techniques and SPC 2
P Status of the publication 'ISO 9000 for Small Businesses' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
E Approval of ISO 9001:2000 - Publication date as 15 December ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Has anyone received the ASQ publication of the DIS for ISO9001:2000? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Z Choice of PTC heater voltage to maximize user safety and ease of CE compliance to LVD CE Marking (Conformité Européene) / CB Scheme 0
Brizilla User Profile - How do I edit my profile info? Elsmar Xenforo Forum Software Instructions and Help 3
T Documenting hazardous situations associated with user/patient population ISO 14971 - Medical Device Risk Management 3
A The refund of 510(k) user fee Medical Device and FDA Regulations and Standards News 0
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 4
D Software User Interface Languages for LVD and IVD CE Marking (Conformité Européene) / CB Scheme 2
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
S Recommendation for user friendly Gaga R&R and Cpk software Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
B ISO 11607-1 for surgical instruments sterilized by end user Other Medical Device Related Standards 1
M User manual / instructions for use for class II device always required? Medical Device and FDA Regulations and Standards News 3
D Do User Manuals (Not Device Labeling) HAVE to be in their national languages for these countries? Will English Hardcopy not do? EU Medical Device Regulations 12
A Cassette Representation - GUI (Graphical User Interface) on my medical device - A mammography Device Other Medical Device Related Standards 0
R Medical device software without user interface Other Medical Device and Orthopedic Related Topics 3
F EUDAMED UDI Medical Devices User's Guide Medical Device and FDA Regulations and Standards News 7
M Informational US FDA Medical Device User Fee Rates for Fiscal Year 2020 Medical Device and FDA Regulations and Standards News 0
K EU MDR Art. 22 - Device + insertion pack - User manual and Labeling EU Medical Device Regulations 4
G Posting Measuring Equipment Accuracy for User Information General Measurement Device and Calibration Topics 4
M Does ISO 13485 or MDR require you to state the origins of customer requirements or user needs? Design and Development of Products and Processes 2
V Sequence of performing risk assessment: User_FMEA (User Errors) vs Design Inputs FMEA and Control Plans 1
Ed Panek Splitting UI (User Interface) into two development paths 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Ed Panek User Feedback both negative and positive and acting upon those metrics 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Detection rating for a user (surgeon) related failure mode in DFMEA APQP and PPAP 3
Marc Search - Search for Discussion Threads started by a specific User Elsmar Xenforo Forum Software Instructions and Help 0
Marc Search for Posts - By specific User Name(s) Elsmar Xenforo Forum Software Instructions and Help 1
M Digital user manuals CE Marking (Conformité Européene) / CB Scheme 0
Marc User Agents of Forum Visitors - 6 November 2018 Forum News and General Information 0
Marc User Post Counts - 20181101 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
Marc Forum User Name - I Want to Change my Forum User Name Elsmar Xenforo Forum Software Instructions and Help 0
Marc 9 September 2018 - Upcoming User Group Changes Forum News and General Information 1
shrutisancheti EU User manual / operator manual / service manual guidance document(s) CE Marking (Conformité Européene) / CB Scheme 2
D How to deal with user needs when it is obvious the design meets the user need 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5

Similar threads

Top Bottom