Medical Device Marketing Material - Control of Social Media

M

margadia

Starting to get Involved
#1
#1
Hi All,

Long time lurker, first time poster. I am the QM for an initial importer/distributor of Class II and III medical devices. We do not manufacture any devices, we work with foreign manufacturers to exclusively sell their devices in the US. We employ a 3rd party distribution warehouse to handle all product, we do not receive in or ship out any devices ourselves. This is a small startup and the QMS is not very robust. I have been developing the QMS but am unsure how to handle document control as it pertains to Marketing material in print or on social media. My main question is, as the importer and not the manufacturer, what are we required to keep track of? We do not produce product labeling as this is all done by the mfr. We do make pamphlets, sell sheets, banners and post on social media about the products. Keeping track of version control for the printed documents is one thing, and I understand controlling what documents we make available on our website but am unsure how social media would play into this. Any feedback would be appreciated!
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Y

yodon

Staff member
Super Moderator
#2
#2
It's a tough one, indeed. It all boils down to claims. If you say the device is used to treat whatever symptom, that's ok because that's what it's (presumably) cleared for. If you say it's 99.99% effective or it can be used in ways that are outside your cleared indicateions then you have a claim. The whole idea is to not mislead the public.
 
M

margadia

Starting to get Involved
#3
#3
yodon said:
It's a tough one, indeed. It all boils down to claims. If you say the device is used to treat whatever symptom, that's ok because that's what it's (presumably) cleared for. If you say it's 99.99% effective or it can be used in ways that are outside your cleared indicateions then you have a claim. The whole idea is to not mislead the public.
Click to expand...
thanks yodon! that's how we have been treating it. cheers!
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T Marketing sticker for Medical Device outer box? EU Medical Device Regulations 8
J Medical Device re-classification and marketing ISO 13485:2016 - Medical Device Quality Management Systems 13
J Control of Medical Device Marketing and Promotional Materials - EU regulation EU Medical Device Regulations 20
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
F Marketing a single medical device with multiple indications Other US Medical Device Regulations 4
J0anne MOC - Sterile Medical Device Marketing - India Other Medical Device Regulations World-Wide 1
C Medical Device Marketing vs. Placing Product on the Market EU Medical Device Regulations 8
R Class II Medical Device - Marketing vs. Indication For Use (IFU) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Significant FDA Medical Device Marketing Shift... 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
C The process for Canadian Marketing of Class II, III, and IV Medical Device Canada Medical Device Regulations 4
K Requirements for Marketing a Medical Device in India Other Medical Device Regulations World-Wide 7
M Medical Device DMR's - List of the Marketing or Market Penetration documents ISO 13485:2016 - Medical Device Quality Management Systems 14
S How to control marketing documents in a medical device company Document Control Systems, Procedures, Forms and Templates 7
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 1
B Documenting Medical Device Complaints after End of Life? Medical Device and FDA Regulations and Standards News 0
M Medical Device License as Distributor Canada Medical Device Regulations 8
M Preparing a document for Raw Material of Medical Device EU Medical Device Regulations 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 0
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
Ed Panek Make sure you hire competent QA RA Folks before making a "Medical Device." Coffee Break and Water Cooler Discussions 1
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 4
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 4
B Reprocessing of an accessory for a medical device EU Medical Device Regulations 4
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0
P Interchangeable/alternative parts in BOM (medical device) Manufacturing and Related Processes 4
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
J Shoe Covers - medical device class I EU Medical Device Regulations 3
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
B A.I. diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 6
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4
Ed Panek Apple Provides New Medical Device Cautions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 5
DanBOS Cloud Connected Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1
S Obsolescence of the Medical Device in Various Countries Other Medical Device Related Standards 1
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 5
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5

Similar threads

Top Bottom