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Sylvie Verdon, FRAPS, MS, RAC

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RE: Canadian Regulation

Posted By Sylvie Verdon 17-Apr-2020 04:20
Found In Egroup: Regulatory Open Forum \ view thread
We would be happy to assist you with your Canadian efforts.  There are a number of inputs that go into determining the product classification and device listing information for Health Canada application purposes.    ------------------------------ Sylvie Verdon; MS, RAC, MPM Senior Consultant; ...

RE: CFDA Issued New Techinical Review Guidelines on Detal Implant Equipment and Soft Contact Lens

Posted By Sylvie Verdon 22-May-2019 07:19
Found In Egroup: Regulatory Open Forum \ view thread
Do you know if there has been any update to the guidance you reference in this communication, technical review guideline on soft contact lens? Also do you know the Chinese classification code for corrective contact lenses and prescription lenses? ------------------------------ Sylvie Verdon; MS, ...

RE: MDR Corrigendum - Tissue Devices?

Posted By Sylvie Verdon 25-Mar-2019 13:07
Found In Egroup: Regulatory Open Forum \ view thread
Commentary: Except for an order change (f « g), there is essentially no change for what is considered a human tissue versus a medical device tissue product between the MDD and MDR.  The text in the MDR provides clarification for the correct regulation/directive which needs to be followed. The MDR ...

RE: Annual Breakfast with Atlanta FDA District Officers

Posted By Sylvie Verdon 27-Oct-2018 14:05
Found In Egroup: Atlanta Chapter \ view thread
I certainly hope you do decide to attend this year's FDA Breakfast event.  This event has historically been attended by approximately 100 area participants.  The attendees range from RA Specialists to the corporate CEOs.  It is an opportunity to ask questions during the presentation portion and during ...