Source Fda 510k Experts for your Project, Phone Consult or Job

Submit an anonymous Inquiry -- Start receiving responses within a few hours

Have a need? Explain it here

Zintro does not display, sell or trade e-mail addresses

An eye iconForgot password?
Submit Inquiry

By clicking Submit Inquiry you agree to our TermsVIEW

or Request a Demo

How Zintro Works

  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.
  2. 2. Within a day or two typically 6 - 12 Experts, who have opted-in, will contact you with a brief explanation of their qualifications and how they can help.
  3. 3. You can communicate back and forth, qualify each other, connect and pay fees to Experts through Zintro.
  4. Zintro is free, anonymous and without obligation.

Loved by Thousands

Loved by thousands logos

Need Help?A phone icon1-877-236-7016

Recent Fda 510k Inquiries

Area Icon

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
Area Icon

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
    Area Icon

    Fda 510k

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

    1. Profile Picture

      James |CEO

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

      8 Minutes Later
    2. Profile Picture

      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
    3. Profile Picture

      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
    Area Icon

    Fda Regulatory Affairs

    With the release of docket no. Fda-2013-n-0487. Manufacture is required to either submit a pma or complete a pdp within 90days. What the advice will be with the following scenario. The company has acquired a 510(k) ecp registered product however the product was not renewal for 2014. The company is in the process renewing the 510(k). The needed the renewal of the product urgently and hesitated which approach should they pursue. The company is new to fda registration and would like to make a decision which is the fastest route.

    1. Profile Picture

      John (Jack) |Founder

      My experience includes successfully ***** 75 510ks and 12 PMAs with extensive experience ...

      3.5 Hours Later
    2. Profile Picture

      Kenneth |Senior Director

      I can advise you as to the best route to FDA clearance. We will need to talk to map the strategy. ...

      4.3 Hours Later
    3. Profile Picture

      Daniel |Clinical Scientist, Regulatory Affairs C

      Dear Mr. , I can definitely advise you regarding best ***** your device. I am an experienced...

      5 Hours Later
    +9 Other Responses
    Area Icon

    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
    Area Icon

    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
    Area Icon

    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
    Area Icon

    510(k) Submission On Medical Device

    We are under serious time constraints on our special 510k filing for a medical device. I have all the paperwork and test loosely together and ready to organize and submit to the fda. If you can help: - are you available to begin immediately - what is the estimated time to submission, assuming all data is received by you? I am ready to move forward immediately. Thank you

    1. Profile Picture

      New |

      Subject: 510(k) Project for Medical Devices Yes, I can assist you till final *****ide ...

      1.6 Hours Later
    2. Profile Picture

      Umberto |Previously: COO, VP & Director Regulator

      Dear. Inquirer, I have a great deal of experience in this area and can help. Please let me know m...

      4.9 Hours Later
    3. Profile Picture

      EE BIN |

      Hi there, our team has done a special K prior and should have the expertise to help. what kind of de...

      5.7 Hours Later
    +48 Other Responses
    Area Icon

    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
      Area Icon

      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
      Area Icon

      Fda 510(k) Guidance

      I would like to get a better understandign of the fda 510(k) process. What is all required in the context of my device. My device is a camera that captures 3d data to allow for highly accurate 3d surface measurements. It will enable better tracking of the healing progress for multiple applications one in particular is chronic wounds. Thank you.

      1. Profile Picture

        Courtland |CEO

        Please contact us about your 510k submission. We can readily help you in ***** requirement...

        9.3 Days Later
      2. Profile Picture

        William |President

        I wanted to follow up on my submission. I believe that the work we have performed on surgical visual...

        22.4 Days Later
      +3 Other Responses
      Area Icon

      Medical Device Manufacturing

      Dear all, we are starting a medical device company related to ivd (its a blood glucose monitoring wearable). We want to make sure to do the right things from the beginning. We would request your quote and timeline on all the following: 1. 510k submission for our class ii - we want someone who can guide on 510k, write the submission, correspond with the fda and get clearance for us. 2. Quality systems- write all sops for us per the fda, train our employees on all the sops 3. R&d - write testing protocols for us, write reports for all performance/bench testing. 4. Create technical file, assist in audit and help in getting ce mark. 5. Finding the right test labs for us and managing test labs. Please advise how much would it cost for each of the above individually. We personally prefer fixed price projects. Looking forward to working with you thanks, ronen

      1. Profile Picture

        Colleen |Owner

        Hello, I have had extensive experience with all of the items you have on your list. I was the Direc...

        51 Minutes Later
      2. Profile Picture

        Umberto |Previously: COO, VP & Director Regulator

        Dear Inquirer, I have extensive experience in all of the areas you have requested and more. 1. I ...

        59 Minutes Later
      3. Profile Picture

        Susan |President and Founder

        I would be interested to discuss further; I have experience in all of these areas. ...

        1 Hour Later
      +29 Other Responses
      See More Inquiries

      Top Fda 510k Experts

      See More Experts
      Share
      LinkedInTwitterFacebookGoogle+