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Yes, if they are obtaining/holding the license actually you will have to give them.all the technical information so they can put together the submission dossier. I would advise against letting a distributor/dealer own the license. This can easily handcuff you in the future. I think you should look for ...

Can it be laser etched or embossed? Or will that create a rough surface not being able to clean? ------------------------------ Ginger Cantor, MBA, RAC Founder/Principal Consultant Centaur Consulting LLC River Falls, Wisconsin 54022 USA 715-307-1850 centaurconsultingllc@gmail.com ----------------- ...

Hi Anon Simply put for the lay person, the DHF (Design History File) is the records of all the planning, design and testing you performed to come up with a medical device product that meets a user need and is robust, safe and effective. You experimented, refined, documented and came up with the ...

Hi Victor I have one contact that may be able to help. Was a packaging engineer for a large company, now a consultant. Contact me offline I need to dig up her contact information. ------------------------------ Ginger Cantor, MBA, RAC Founder/Principal Consultant Centaur Consulting LLC River ...

Hi Nancy This is a rather broad question. Which records? Audit trails on eQMS ERP document systems and lab equipment (e.g., HPLCs, etc.)? Training records? HR items?- nope; Financial revords, nope. Inform legal counsel, closely supervise if legal counsel oks, note exactly which records ...