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Recent 505b2 Inquiries

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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.

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    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
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    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

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

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    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
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    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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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

    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
    2. Profile Picture

      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.

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      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
    3. Profile Picture

      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 Filing

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

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      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

    A pma submission expert for a submission of a new cosmetic filler similar to radiesse that could possibly be combined with a lidocaine for pain management and would be delivered with thawed cryo-preserved amniotic allograft component that is mixed once in a liquid format state. The expert must be willing to testify in court.

    1. Profile Picture

      Michael |Regulatory Project Manager

      *****irs Associates (RAA) can assist with your device submission. RAA has completed over ...

      1 Minute Later
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      Plamena |Principal Consultant

      Preferred *****ulting has PMA experience including for *****ucts and loads of C...

      1 Minute Later
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      DANIEL |CEO

      Hello. We are a group of medical device consultants including expertise in quality Management and FD...

      1 Minute Later
    +8 Other Responses
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    Fda 510k

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

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      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

    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.

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      Michael |Regulatory Project Manager

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

      5 Minutes Later
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      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
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      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

    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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      Medical Device 510k

      We are a contract manufacturing company. We have a medical device manufacturing license from the state of california. We manufacture private label personal lubricants that now require 510k approval by the fda. Our customer that we manufacture the lubricants for has gotten 510k approval on his product, but that is only for his brand. As a contract manufacturer we must get 510k approval on our formula and list what brands we produce it under. I need a consultant that has 510k experiences.

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        Parul |Regulatory Consultant, Elexes Inc.

        I have done successful 510k submissions, and would love to do this job for you! Why am I a good fi...

        22 Minutes Later
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        steve |ceo

        HI, Happy to get your *****red through the 510k process. I and my small team have gotten ...

        25 Minutes Later
      3. Profile Picture

        Timothy |Principal

        I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Qualit...

        33 Minutes Later
      +35 Other Responses
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