Regulatory Open Forum

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  • 1.  Looking for consultant for wound dressing 510(k)

    Posted 13-Jan-2014 18:26
    I am looking for someone who can take care of a company in Europe seeking 510(k) clearance for a wound dressing.

    Fluent German is a must.

    Please contact me directly if you are interested or would like to recommend a colleague.

    Thank you,

    Jean
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    Jean Bigoney PHD
    Managing Member
    Nu Device Consulting LLC
    Newport NH
    United States
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  • 2.  RE:Looking for consultant for wound dressing 510(k)

    Posted 14-Jan-2014 08:57
    Dear Jean,

    We would be happy to assist you with the wound-dressing medical device, if I understand well this is a 510(k) in the US and needs CE-marking in Europe ? I would have the technical and regulatory competences for the CE-marking and am German speaking. In our consultancy group we also have a medical doctor specialised in wound-healing. You may have a look at our website ( www.camara-partners.com ) or contact me to discuss your needs (cornelia@camara-partners.com), with best regards, Cornelia

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    Cornelia CAMARA
    Expert Partner and Managing Director
    Camara and Partners
    Nyon
    Switzerland
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    Original Message


  • 3.  RE:Looking for consultant for wound dressing 510(k)

    Posted 14-Jan-2014 09:18
    i could help n- look forward to hearing from you.


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    Elias Nyberg DVM, MBA,MRCVS,MACVS
    Vice President, Regulatory Affairs
    email:elisha_nyberg@yahoo.com
    Stow MA
    United States
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    Original Message


  • 4.  RE:Looking for consultant for wound dressing 510(k)

    Posted 15-Jan-2014 14:21
    Hi Jean:

    We are based in the UK and work about 30% for German Customers mainly on FDA submissions and QSR issues. I think I would have to say we have business German rather than fluent - whether that is enough I leave up to your discretion, but if we can help I am sure we would be hapy to try.

    Best regards

    Neil

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    Neil Armstrong RAC
    CEO
    MeddiQuest Limited
    Cambridgeshire
    United Kingdom
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    Original Message