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Recent Fda 510k Inquiries

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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
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    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

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
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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

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
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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

Need a special 510k written for a class ii device that includes hardware. Will also need new risk analysis, design controls, testing, and procedures written for bench testing. Looking for pricing, even if it is estimated.

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    steve |ceo

    Hi. We've done over 100 special 510k's and all that goes with it. Happy to quote price range, confi...

    38 Minutes Later
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    Les |Principal

    With more than 40 years in the *****stries and a successful track records of submission...

    39 Minutes Later
  3. Profile Picture

    Hrishikesh |Consultant

    We can definitely work on preparing all aspects of a 510(k) submission. The pricing will depend on ...

    45 Minutes Later
+20 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
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    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

    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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    Clinical Study For 510k Of An Ivd

    Hi experts, we are working on a blood glucose meter and want to conduct human factors and clinical testing to support 510k submission to the fda. In your experience can we conduct these testing outside us? Can you help us perform: 1) human factors study 2) clinical study please let me know

    1. Profile Picture

      Umberto |Previously: COO, VP & Director Regulator

      Dear Inquirer, I do have experience in this area. The answer to your question on whether the clin...

      1.8 Hours Later
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      Asad |Zintro Expert

      Enquirer: We have extensive experience in devloping and getting products through FDA especially in d...

      2.1 Hours Later
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      Eugene |Scientific Director

      Hello. I'm MD, Medical Director of CRO from the UK. We can assist with this( 1and 2). Our website. w...

      3.1 Hours Later
    +16 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
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      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

    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
    3. Profile Picture

      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

    Canadian company personal lubricant class ii medical device prepare 510k submission

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      James |CEO

      To Whom it May Concern, my company is one of the premier leaders in the ***** 510k submissi...

      8 Minutes Later
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      Larry |Served as CEO, VP Sales and Marketing, R

      Dear sir, I am responding to your posting on Zintro for an FDA 510(k) expert consultant. This is ...

      10.2 Hours Later
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      Georganne |Consultant

      Hi, I have been a *****essional for over 35 years, specializing in medical devices. As a c...

      12.5 Hours Later
    +8 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.

    1. Profile Picture

      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
    2. Profile Picture

      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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