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Recent 510 K Inquiries

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Medical Device 510 (k)

If your are manufacturing hematology controls and file a 510(k) and decide to move to another location. Do you have to re-file a new 510(k) for the new location.

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    Al |Founder and Consultant

    No, you do not need to file a new 510(k). The 510(k) is a marketing clearance and does not involve ...

    13.6 Hours Later
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    George |Prinicipal Quality Consultant

    No, 510k not required, but compliance to QSR / 21CFR820 is required and in relocation of a process r...

    2.1 Days Later
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    Russell |President/Owner

    No a 510(k) will not be required. I would recommend investigating the re-validation of all your ma...

    42.8 Days Later
+6 Other Responses
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510(k)

Dear sir, i represent *************medical engineering pvt. Ltd., mumbai india.George philips was established in 1995 and today, is one of india's leading manufacturer and supplier of 'life saving medical devices and disposables' to the healthcare industry, both domestically and internationally. I am writing to express my interest in seeking your assistance for the submission of 2 of our products (iv flow regulator and disposable pressure transducer kit) for 510 k approval.Kindly provide a quote for processing our application. Awaiting your reply at the earliest.

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    Avner |Quality & Regulation Advisure

    Hello, I'm highly experienced with 510K submissions consulting I will be happy to support you with ...

    1.2 Hours Later
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    Joseph |President

    Dear Sir, I would be happy to participate in the preparation and submission of your 510(k)'s to the ...

    1.6 Hours Later
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    Yong |Principal Consultant

    Hello, I worked on IV infusion pumps and assessed IV flow regulator designs at Siemens Infusion and...

    3.3 Hours Later
+20 Other Responses
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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.

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    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
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    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
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    Georganne |Consultant

    What types of products are involved?...

    1.5 Hours Later
+28 Other Responses
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Medical Device Approval

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

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    Jay |President, VP Sales, Marketing Director

    I can help you in this area. Contact me at 619-885-4035 or at Jevans@TekArtis.net I have also don...

    6 Minutes Later
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    Andrea |Principal Consultant

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

    7 Minutes Later
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    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
+34 Other Responses
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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.

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    Cynthia |Regulatory Affairs Consultant

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

    16 Minutes Later
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    Courtland |CEO

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

    3.9 Hours Later
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    New |

    Can we talk early next week. Pem Guerry, pguerry@signix.com, 423-298-4438...

    1 Day Later
+12 Other Responses
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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.

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    Denise |Independent Consultant

    I have 17 years experience with FDA 21 CFR 820 and the most current requirements of the 510(k) proce...

    6.1 Hours Later
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    Nicholas |Principal Consultant

    I have substantial knowledge of the wound healing market as well as experience with the FDA 510K pro...

    8.6 Hours Later
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    Susan |President and Founder

    I would be glad to discuss this project with you. I have given a presentation on the new guidance d...

    15.2 Hours Later
+11 Other Responses
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510(k) Clearances

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

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    Daniel |Clinical Scientist, Regulatory Affairs C

    Hi, Regulatory Affairs Professional with a proven track record of successfully obtaining more than 1...

    1.6 Hours Later
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    Constance |President

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

    2.7 Hours Later
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    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
+20 Other Responses
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510(k) Clearance

I'm doing a 510k and would like someone to review before i submit.

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    Shelly |General Partner, Eureka! Bioscience and

    The FourCe, LLC is experienced with 510k's production and review. Contact us today to discuss how w...

    7 Minutes Later
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    Michael |Regulatory Project Manager

    Regulatory Affairs Associates (RAA) is a premier regulatory consulting firm. We have successfully s...

    17.3 Hours Later
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    Parul |Sr Regulatory Specialist

    The most important elements for obtaining a timely FDA clearance is having the right Predicate, prop...

    17.8 Hours Later
+14 Other Responses
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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.

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    Cynthia |Regulatory Affairs Consultant

    Hello, I am an independent regulatory consultant specializing in class I and class II medical devic...

    4.8 Hours Later
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    Jorge |

    Dear Cindy, would like to discuss with the you how feasible such can be prior to retaining you. were...

    7.5 Hours Later
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    Daniel |Clinical Scientist, Regulatory Affairs C

    Dear Mr/Mrs, I am confident I can help you in you project to get this device to the market in the s...

    13.2 Hours Later
+13 Other Responses
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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.

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    Christopher |Principal Consultant

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

    1 Minute Later
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    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
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    Eric |Regulatory Associate

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

    1 Minute Later
+22 Other Responses
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510(k)

I manage a fda accredited third party review company. We are expanding our accredited reviewer pool and seeking individuals with extensive 510(k)submission and review experience. This is a contract opportunity. Please contact me if available and interested.

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    steven |Consultant

    I have 510(k) experience and would be interested....

    31 Minutes Later
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    Ken |President

    I have filed and received 510(k)s on numerous medical devices and clinical diagnostic products. I c...

    38 Minutes Later
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    Ronen |Engineer & QA/RA specialist

    Dear Sirs, I am interested and available in Australia and the surrounding region. Once a contact is...

    46 Minutes Later
+29 Other Responses
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510(k)

I am the ceo of a new medical device startup. Our device is a new type of orthodontic aligner appliance. I have sufficient funding for regulatory analysis, we just want a rudimentary analysis done to better understand our path. I want to know why some aligners are classified under fda 21 cfr 872.5470 (class ii) and others were classified under 872.5410 (class i). Thanks

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    Daniel |Clinical Scientist, Regulatory Affairs C

    null...

    2 Hours Later
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    Jim |Consultant

    Hello, I would be happy to provide this service. It should be a fairly straightforward analysis. Bes...

    4.2 Hours Later
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    Craig |Consultant

    Hi, My name is Craig Pagan and I am a partner with C2C Development (www.c2c-dev.com) a medical devic...

    4.6 Hours Later
+22 Other Responses
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