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  1. 1. Provide a clear description of your needs and your expectations of an expert, consultant or job candidate and Zintro will match it with the most relevant professionals in our platform.
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Recent 505b2 Inquiries

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505b2 For Drugs

We require an expert to assist with 505b2 for a drug/device combination. We are repurposing an existing inhalation device coupled with a medical gas for home use. We plan to submit to the fda within 3-4 months and need help asap. We are looking for remote collaboration, thus location is of no importance. 505b2 has to be your core expertise. Referrals are also welcomed, thank you.

    +undefined Other Responses
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    Fda 510k

    I need someone to write a fda 510k for a class ii product.

    1. Profile Picture

      James |CEO

      To Whom it may Concern, I have 15+ years working with Class II medical devices. I have worked with ...

      4.3 Hours Later
    2. Profile Picture

      Andrea |Principal Consultant

      Good Afternoon, I have about 20 years of experience in medical device *****irs, I can wri...

      4.7 Hours Later
    3. Profile Picture

      Paul |CEO and Co-Founder

      Please contact our in-house *****irs expert, Rich Anderson at (916) *****....

      4.8 Hours Later
    +24 Other Responses
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    Fda 510k

    We are a small medical device company. I have a fda cleared device and i want to add an indication for which no predicate exists. Fda recommended de novo 510(k). I have engaged hogan lovells to manage this submission but i need someone to be our arms, legs, and mind to prepare for pre-sub fda meeting and assist in submission creation. I need a hands-on doer to do real work, not just someone to tell me what to do. This is an exciting new product that is making a difference in lives. It is ce marked and approved in many countries. We are based in gaithersburg maryland just north of washington, dc.

      +undefined Other Responses
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      Fda 510k

      A company that makes personal lubricant class ii medical device is looking for consultants with personal lubricant 510k submission experience

      1. Profile Picture

        John |Owner and Sr. Consultant

        My ***** filed numerous personal lubricant 510(k)s. We would be pleased to do this work on ...

        1.5 Hours Later
      2. Profile Picture

        Anne |Zintro Expert

        I have worked on many 510(k)s for medical devices (class II). I am a medical writer based in Chicago...

        2.2 Hours Later
      3. Profile Picture

        Diane |Zintro Expert

        As a former FDA reviewer and 15+ years of experience in the medical device industry preparing 510Ks ...

        9.1 Hours Later
      +10 Other Responses
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      Pma 510k Fda

      I'm looking for a medical device consultant that has expertise in fda submissions for some or all of the following: pma, 510ks, ide, or de novo. Onsite consulting may be required for a few days a month and up to 2 weeks a month.

      1. Profile Picture

        Larry |Plastic Surgeon, Entrepreneur, and Medic

        Hi, I am an experienced physician and medical device expert with clinical and *****rience...

        23 Minutes Later
      2. Profile Picture

        Nancy |Managing Member

        My partner and I have industry experience with Class III device PMAs and IDE submissions as well as ...

        4.3 Hours Later
      3. Profile Picture

        Courtland |CEO

        Please contact us about your devices to see how we can help with your *****tegy. We have...

        5.5 Hours Later
      +14 Other Responses
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      Fda 510k

      We are looking for partners in us who take care of fda c-1,2,3 and 510k and clinical trial. We have many customers who need the services. If of interest please contact me via zintro.

      1. Profile Picture

        Ana Maria Saaibi |Director of Regulatory Affairs

        Hi, We are a consulting company with more than 7 years of experience in *****irs for medic...

        2.8 Hours Later
      2. Profile Picture

        Cynthia |Regulatory Affairs Consultant

        Hello, I am an independent consultant specializing in class II 510(k) submissions. Please contact m...

        6.3 Hours Later
      3. Profile Picture

        Courtland |CEO

        Please let us know how we can assist you. Our firm is celebrating 11 years. Our average age in i...

        6.6 Hours Later
      +14 Other Responses
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      Fda 510k For Light Therapy Device

      We need to determine whether or not a led light therapy device needs a 510k. We have seen some led light therapy devices have a 510k and some do do not. Looking for someone with expertise in this specific area.

        +undefined Other Responses
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        Fda 510k Filing

        I need an independent consultant to file substantial equivalence 510 k with fda

        1. Profile Picture

          Polina |Zintro Expert

          I support 510K fillings for drug products. Email me at ***** ...

          1.6 Hours Later
        2. Profile Picture

          Ee Bin |Owner & Consultant

          Hi there, is it a device or drug or *****ce or IVD? cheers, Ee Bin www.access2hc.com...

          2.6 Hours Later
        3. Profile Picture

          Parul |Regulatory Consultant, Elexes Inc.

          I would love to help you on this. I have done a number of 510(k) fillings and successfully gotten FD...

          5.3 Hours Later
        +29 Other Responses
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        Fda 510k

        Need an independent fda 510k consultant to prepare a 510k submission. Not looking for consulting groups. Must be a single person seperate from a group.

        1. Profile Picture

          Larry |Served as CEO, VP Sales and Marketing, R

          Hello, I am an FDA 510(k) consultant with 25 years of experience. I work alone and I do this type o...

          7 Minutes Later
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          Antonio |Director

          I have submitted several successful 510ks and 510k with clinical trials. I alos have access to over ...

          46 Minutes Later
        3. Profile Picture

          James |Owner

          Class II? Class III? Timeframe? Onsite or remote or both? I authored FDA 510(k) K*****. Jim Joy...

          1.1 Hours Later
        +29 Other Responses
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        Fda 510k

        Hello, i'm looking for a consultant to assist with an fda 510k submission for a: class ii ophthalmic medical device if you have expertise in this area, please let me know. Thank you.

        1. Profile Picture

          Les |Principal

          I have more than 40 years in the *****stries and have successfully submitted numerous 5...

          1 Minute Later
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          Mark |Clinical Associate Professor, Oregon Hea

          I have helped many companies achieve 510k clearance for ophthalmic devices, from imaging systems to ...

          4 Minutes Later
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          LAWRENCE |President and Ph D

          Please see my profile. I have worked as VP for a major company for contact lenses. I have been consu...

          6 Minutes Later
        +24 Other Responses
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        Fda 510k

        I need a consultant to assist my client with litigation involving the use of 510k. The case is in florida, and i am in ny.

        1. Profile Picture

          Michael |Regulatory Project Manager

          President of *****irs Associates, Stephen Goldner, has 40 years experience in regulatory a...

          5 Minutes Later
        2. Profile Picture

          Charles |VP, Sr Director, National sales Mgr, VP

          Yes we can help. We do assist clients in the 510k are in all facets. If you want to further discuss ...

          14 Minutes Later
        3. Profile Picture

          Timothy |Principal

          I am former FDA and as a consultant for 18 + years I have furnished clients with quality system audi...

          15 Minutes Later
        +19 Other Responses
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        Fda 510k

        Looking for a seasoned 510k submission expert with significant proven experience with ivds. - need someone with experience in the gastrointestinal space, medical devices and colonoscopy.

          +undefined Other Responses
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