Source 510 K 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 510 K Inquiries

Area Icon

Fda 510(k) Guidance

We are developing a simple device that connects a pill container to a smartphone to monitor pharmaceutical adherence. We need guidance on the 510(k) process for development of both our physical product and our software before we go to manufacturing.

  1. Profile Picture

    John |Owner and Sr. Consultant

    ***** discovering another ***** of mobile technology that helps people manage ...

    4.7 Hours Later
  2. Profile Picture

    steve |ceo

    Great idea. We've gotten about 30 computer / wireless software apps reviewed and cleared, plus many ...

    5 Hours 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...

    5.2 Hours Later
+22 Other Responses
Area Icon

510(k) Submission

In search of independent senior level consultant possessing extensive 510(k) medical device submission review experience. Prior fda division review experience is highly desirable. This is project work that can all be performed remotely.

  1. Profile Picture

    Brett |CEO

    Hello, I operate a small health consulting group and have an expert in FDA work. He has over 25 ye...

    17 Minutes Later
  2. Profile Picture

    Andrea |Principal Consultant

    Please contact me to discuss. I have solid 510(k) experience, with 510(k) gap analysis and remediat...

    1.4 Hours Later
  3. Profile Picture

    Georganne |Consultant

    What types of products are involved?...

    1.5 Hours Later
+17 Other Responses
Area Icon

Fda 510 K

I am looking for a consultant with 510(k) experience to perform a review of a 510(k) that has been generated.

  1. Profile Picture

    Christopher |Principal Consultant

    Hi, I can assist you with your *****irs needs. Please send me an email and we can provide...

    1 Minute Later
  2. Profile Picture

    Susan |Consultant (former CMO)

    Hello, I have 510K experience as a partner in a healthcare IT company; are you looking for an editor...

    1 Minute Later
  3. Profile Picture

    Eric |Regulatory Associate

    I can certainly perform a review of your 510k....

    1 Minute Later
+19 Other Responses
Area Icon

510(k) Submission

Requirement for senior level experience in reviewing class i and class ii 510(k) submissions. Prior fda experience is desirable along with 20+ years industry specific device experience. Member should be able to review and assess the 510(k) contents at the levels of rta checklist, substantive review and be able to provide written assessment for determining fda recommendation for substantial equivalence. This is a contract position.

  1. Profile Picture

    steve |ceo

    HI, Happy to do this project for you. I've been reviewing class1 and 2 [510ks] for 35 years. Please ...

    28 Minutes Later
  2. Profile Picture

    Kenneth |Senior Director

    What is the device? I am an expert in IVDs. Prefer that *****ce. 20+ years senior level e...

    32 Minutes Later
  3. Profile Picture

    Jonathan |President

    I have experience in dialysis filtration, ***** sterility assurance products, and washer...

    35 Minutes Later
+28 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 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

510(k) Clearances

Interested in expert to help us file a 510(k) clearance for non-invasive radiofrequency and cavitation system.

  1. Profile Picture

    Daniel |Clinical Scientist, Regulatory Affairs C

    Hi, *****irs Professional with a proven track record of successfully obtaining more than 1...

    1.6 Hours Later
  2. Profile Picture

    Constance |President

    I have over 30 years experience as a medical device FDA *****ultant including preparing, s...

    2.7 Hours Later
  3. Profile Picture

    Monther |Sr. Manager

    Hi, I am interested in consulting and submitting the 510(k) for your device. My background is electr...

    3.5 Hours Later
+13 Other Responses
Area Icon

510(k) Review

We need help to move 510(k) through the whole process. It is a class ii dental device of very low risk. Please let me know: 1) how many 510(k) have you filed in the past and how many cleared 2) how do you charge and what is the ball park for your fee. Thanks!

  1. Profile Picture

    Al |Founder and Consultant

    Although most consultants can give you advice, not all consultants will have the right successful st...

    23 Minutes Later
  2. Profile Picture

    Larry |Principal Consultant

    I would say at least 30 over the years all successful, except for one which still under review. The...

    25 Minutes Later
  3. Profile Picture

    Cynthia |Regulatory Affairs Consultant

    I have a wide range of experience in working with 510(k) submissions, with one in the past year for ...

    30 Minutes Later
+22 Other Responses
Area Icon

510 K Submission

I am looking for an fda consultant in the massachusetts area, experienced with 510k submissions

  1. Profile Picture

    James |CEO

    To Whom it May concern, I am an expert consultant who has sucessfully submitted and had cleared over...

    2.7 Hours Later
  2. Profile Picture

    Roy |President & CEO

    Depending on your specific requirements, we can likely help. Our practice is focused on go-to-marke...

    3.2 Hours Later
  3. Profile Picture

    Karl |President

    We are ***** Dover, NH just north over the border from Massachusetts and we develop medical dev...

    3.5 Hours Later
+17 Other Responses
Area Icon

510(k)

**** provides secure digital signature technology that is fda compliant. We are looking for partner(s) to participate in fda's 510(k) e-submission pilot.

  1. Profile Picture

    Cynthia |Regulatory Affairs Consultant

    Hello, I am an independent *****ultant that assists small and start-up medical device manu...

    16 Minutes Later
  2. Profile Picture

    Courtland |CEO

    We are very familiar with ESG and FURLS and look forward to helping you verify the transmission. ...

    3.9 Hours Later
  3. Profile Picture

    Jonathan |Consultant

    Hello, I am confident that our consulting firm has the resources to meet your needs and would love t...

    3.6 Days Later
+7 Other Responses
Area Icon

510(k) Clearance

Interested in filing a 510(k) clearance or class 1 filing for radio frequency and aesthetic system, we already have catalog. Interested in flat rate, need proposal, we just became premium member, would like a 15-30 minute conversation prior to contrating.

  1. Profile Picture

    Cynthia |Regulatory Affairs Consultant

    Hello, I am an independent *****ultant specializing in class I and class II medical devic...

    4.8 Hours Later
  2. Profile Picture

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

    Jorge, I think Zintro is blocking my email address and telephone so I do not know how to contact y...

    1.3 Days Later
  3. Profile Picture

    Jonathan |Consultant

    Hi RFtrainer, We have resources available who are perfect for this project. If you are interested in...

    1.3 Days Later
+10 Other Responses
Area Icon

Medical Device Approval

Need to get guidance on 510 k submission for new device i'm patenting

  1. Profile Picture

    Jay |President, VP Sales, Marketing Director

    I can help you in this area. Contact me at ***** or at ***** I have also don...

    6 Minutes Later
  2. Profile Picture

    Andrea |Principal Consultant

    Hello, I am a medical device consultant with 20 years of experience with 510(k) submissions and pro...

    7 Minutes Later
  3. Profile Picture

    Richard |Medical Device Expert

    I would need to know a little more about the device... What general field is the medical device used...

    9 Minutes Later
+27 Other Responses
See More Inquiries

Top 510 K Experts

See More Experts
Share
LinkedInTwitterFacebookGoogle+