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Recent Fda Compliance Inquiries

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510k

This is an independent consultant/reviewer position: requirement for a senior level person with 15+ years of experience in 510(k) medical device submissions. Individual should possess an extensive knowledge of 510(k) submission requirements to include format, content, and fda compliance requirements for class i and class ii devices by specific product code. Work entails submission reviews from a fda perspective and covers all ode branches. This work can will be performed remotely.

  1. Profile Picture

    Daniel |Clinical Scientist, Regulatory Affairs C

    Dear Mr./Mrs: Is this project for work as FDA reviewer? Regards Daniel Ramirez ...

    16 Minutes Later
  2. Profile Picture

    Cynthia |Regulatory Affairs Consultant

    I am an independent medical device *****ultant specializing in class I and II medical devi...

    21 Minutes Later
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    Georganne |Consultant

    I am sure I could assist this client. I am an independent consultant with over 37 years of regulat...

    32 Minutes Later
+20 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

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
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    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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510k Clearance

We are a microcurrent therapy product development company. We are 90% completed with our fda 510(k) prescription only submission for a class ii tens device. Our regulatory consultant has had to take a leave of absence. We need a regulatory affairs consultant to help us complete the submission asap.

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    Ram |CEO-Founder

    We can assist with this. Ram Balani...

    1 Minute Later
  2. Profile Picture

    Alan |President and Senior Consultant

    We have the experience needed, and will commit to *****ort. Looking forward to our success...

    1 Minute Later
  3. Profile Picture

    Daniel |Clinical Scientist, Regulatory Affairs C

    I can help you complete your 510K ASAP. Have extensive experience and 100% success ***** back to...

    1 Minute Later
+20 Other Responses
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Fda Pre-submission

Hi! we need a pre-submission to define the regulatory strategy for an innovative yet simple electrical non invasive medical device serving an under served population of patients. I understand that you might need more details, but i just want to check if the pricing is within our budget. Please let me know what will be your ballpark quote (or price range) and timeline for the following. If your price range is within our budget, i will contact you to move forward with the project. 1. Advising on what things will be needed for preparing a pre-submission. 2. Preparing all sections of the pre-submission. 3. Corresponding with the fda and answering all questions on the pre-submission. 4. Scheduling a meeting with the fda and discussing questions that need to be clarified to clearly define the regulatory strategy (eap/denovo/pma, etc). 5. Creating a final report for lir on regulatory path and testing needed, moving forward, based on the discussion with the fda. Also if we need a 510k. What are the typical timeline and rates for a 510k? Thanks a lot! sumi

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    Alan |President and Senior Consultant

    Dear Sumi, I would be happy to help, and have a background both in such medical devices (including t...

    4.2 Hours Later
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    steve |ceo

    Hi Sumi, We are happy to help, having accomplished over 230 successful medical device submissions to...

    4.3 Hours Later
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    Les |Principal

    Hi Sumi, I can assist you with your project. I have more than 40 years of experience and have a su...

    4.6 Hours Later
+15 Other Responses
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Fda Compliance

Need a special 510k filed with all the proper tests for our implantable medical device? Immediate need!

  1. Profile Picture

    New |

    Hello, I was a study director for long-term implantable products and handled ***** (in-v...

    2.6 Hours Later
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    Prabodh |Sr Manager R&D

    I have over 25 years experience in medical devices. I have experience in the areas of FDA and CE reg...

    2.8 Hours Later
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    James |CEO

    To Whom it May Concern, I have over 15 years of 510(k) experience. I am a former reviewer for the ...

    2.8 Hours Later
+21 Other Responses
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Fda Compliance

We are a small implantable medical device company in ny in expert of an fda compliance expert who can assist us with an upcoming audit.

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    Marie |Regulatory compliance/Quality System/ASQ

    Hello: I believe I can assist you with your audit needs. I have worked with small device companies...

    1.3 Hours Later
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    Scott |Consultant / Owner

    Hi, I have implemented several FDA compliant systems. If you could provide more ***** wou...

    1.3 Hours Later
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    Eugene |Scientific Director

    My company can do it. We are Auditors from Europe ...

    1.4 Hours Later
+17 Other Responses
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Fda Compliance

Looking for a former fda compliance expert in drugs specializing in data integrity and quality metrics. This engagement is for october 2016

    +undefined Other Responses
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    Fda Medical Device

    I need help filing a special 510k for my product. Thank you

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

      Hello, I am an FDA *****irs Consultant. I prepare Special FDA 510(k) submissions for Medi...

      7 Minutes Later
    2. Profile Picture

      Les |Principal

      I can help you with this as I've successfully submitted numerous 510(K)s. Please contact me at fdaq...

      10 Minutes Later
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      NO WAY TO |Chief Experience Officer

      We can help with the usability aspects iso ***** for your 510k by conducting and reporting on your s...

      16 Minutes Later
    +13 Other Responses
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    Fda Compliance

    I am looking for speaker/consultants form fda compliance industry who are ex fda's . Please drop me a message if this is suitable & this is for engagement in 2015 .

    1. Profile Picture

      Timothy |Principal

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

      5.2 Days Later
    2. Profile Picture

      Mithilesh |Advisor

      I am not from FDA. However, have more than 30 years experience in Pharma Sector & presently working...

      5.7 Days Later
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      Balvant P |PRESIDENT

      I have a proven expertise / experience in the overall areas of Quality (QA/QC) / FDA's GxP Complian...

      5.8 Days Later
    +5 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
    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 Compliance

    Looking for a retired fda compliance expert to work part time. Writing, reading, finding devices, predicates etc

    1. Profile Picture

      Bob |Principal Consultant

      I am not a retired FDA but I help FDA *****nts with quality systems remediation, implementa...

      22 Minutes Later
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      Georganne |Consultant

      While everything should be compliant with the law, those charged with *****liance are gene...

      6.8 Hours Later
    3. Profile Picture

      Les |Principal

      Please contact me at ***** we can schedule a no-fee initial call. Also, please re...

      20.7 Hours Later
    +5 Other Responses
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