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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 510k Inquiries

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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
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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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Fda Medical Device

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

  1. Profile Picture

    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
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    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 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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Medical Device

I need a 510k for a device. I believe it would be abbreviated since its already in the market, just a different brand.

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    Monther |Sr. Manager

    Hi, I'll be glad to assist you with your 510(k) submission. But the question I have is a submission ...

    4 Minutes Later
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    Jim |Principal

    i'd be happy to help...

    13 Minutes Later
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    Al |Founder and Consultant

    510(k)s are not only market clearance submissions but they can establish a valuable *****e...

    27 Minutes Later
+38 Other Responses
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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.

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    Daniel |Clinical Scientist, Regulatory Affairs C

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

    16 Minutes Later
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    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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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

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    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
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    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
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    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
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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
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    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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Medical Device Regulatory Affairs & Quality Assurance

To plan, file, and prepare regulatory, and 510k submissions for fda on new or substantially changed products. In addition the incumbent will prepare technical files in support of ce marking, and maintain compliance with applicable device regulations including support of fda udi requirements. Finally the incumbent will serve as regulatory representative on selected project teams for new product design as well as project teams for process development, developing departmental sops/policies regarding regulatory requirements and processes. Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting. Competitive salary and benefits. Relocation offered. Job responsibilities: manage daily activities of regulatory affairs and quality assurance personnel implement all regulatory and quality assurance activities according to in-house procedures and regulatory requirements establish qa procedures for internal and vendor compliance with the fda and international regulatory requirements, quality regulations and guidelines communicate with regulatory agencies; provide oversight to ensure that the company is 100% compliant with us and international regulatory requirements lead regulatory affairs and quality assurance during fda inspections, notified body audits and internal audits; participate in all respective agency audits and responses to support audit findings or other respective actions related to such audits determine the types of regulatory submissions or internal documentation that are required, in situations such as proposed device changes, and maintain regulatory clearances and approvals with necessary filings and communications prepare fda premarket submissions (including fda 510k) and technical files as required for new and updated products qualifications: **must haves** bachelor’s degree in a scientific or engineering field or equivalent combination of experience. Minimum of 5 years working in the medical device industry within regulatory affairs role is required. Must have direct, lead role fda/iso audit experience must have proven ability to prepare and submit documents to fda, such as 510(k) premarket notifications, investigational device exemptions (ides), and premarket approval applications, (pmas); must have proven successful ce marking of devices through design dossier or technical file process. Location: greater philadelphia area, pa

    +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.

    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
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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
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      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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    Wound Care Medical Device

    Subject -- wound care medical device 510k / pma hi all, we are looking for expert who has done a wound care 510k or pma submission this year or last year. We are looking for a long term engagement. We do not need help writing the submission, but we only need advise on deciding what claims we can make or not make, what type of concerns fda has expressed in the recent submissions, and will the product be subject to a 510k or a pma submission. Please do let us know your hourly rate. Thank you! jasmine

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      Courtland |CEO

      Jasmine, Our team has a wound care expert. 33 years experience. Many submissions and product deve...

      4.8 Hours Later
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      steve |ceo

      Hi Jasmine, We have a number of long term clients, start-up and well established companies to who we...

      4.9 Hours Later
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      Michael |Regulatory Project Manager

      Hi Jasmine, *****irs Associates (RAA) has successfully submitted over 200 medical device s...

      5.1 Hours Later
    +13 Other Responses
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    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
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      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
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      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
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    Fda Compliance

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

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      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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