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MS Lin Wu, RAC

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United States

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1 to 5 of 50+ total

RE: Trade show/conference booth review

Posted By Lin Wu 06-Sep-2022 10:02
Found In Egroup: Regulatory Open Forum \ view thread
Hello Anon, there was a prior post in this community titled "REGULATORY ROLE AT TRADE SHOW" that has some valuable information on trade shows.  You may also find another discussion thread titled "HOW DO VIRTUAL EXHIBITS DIFFER FROM IN-PERSON EXHIBITS?" in 2020 helpful. It was helpful to me when I was ...

RE: Advertising and promotion of medical devices in EU and US of a non approved product

Posted By Lin Wu 03-Mar-2022 16:54
Found In Egroup: Regulatory Open Forum \ view thread
Here are a few tips I can think of: For devices pending clearance or approval, can show in a trade show, however, 1) must include pending approval/clearance and state clearly currently under review 2) can display, but not take orders 3) Can accurately describe functions of the device 3) cannot suggest ...

RE: Hypothetical Questions

Posted By Lin Wu 23-Feb-2022 15:57
Found In Egroup: Regulatory Open Forum \ view thread
It's worth looking into more details.  I'd say depends on what type of serious design issues.  It would be good to find out what type of serious design issues. Search reported events from the FDA's TPLC website using the product classification code gives one source of information, however, it may ...

RE: Different product names (medical device) worldwide - use in marketing material

Posted By Lin Wu 17-Feb-2022 10:44
Found In Egroup: Regulatory Open Forum \ view thread
If your company has local RA offices or agents who handle local registrations, you may send a survey to ask for feedback from each local office where products are registered.  I am not sure if this is helpful however I thought it would be good to get feedback directly from local who knows their current ...

RE: The RA professional's anxiety- a reality? or is it just me :)

Posted By Lin Wu 13-Jan-2022 11:18
Found In Egroup: Regulatory Open Forum \ view thread
Thank you all for the discussions, and thank you, Paul.  I read the Code of Ethics again today, very important! ------------------------------ Lin Wu, RAC ------------------------------