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Recent Fda 510k Inquiries

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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
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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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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 |Sr. Consultant

    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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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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Fda 510k

Need a special 510k written for a class ii device that includes hardware. Will also need new risk analysis, design controls, testing, and procedures written for bench testing. Looking for pricing, even if it is estimated.

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    steve |ceo

    Hi. We've done over 100 special 510k's and all that goes with it. Happy to quote price range, confi...

    38 Minutes Later
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    Les |Principal

    With more than 40 years in the *****stries and a successful track records of submission...

    39 Minutes Later
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    Hrishikesh |VP of R&D and Manufacturing

    We can definitely work on preparing all aspects of a 510(k) submission. The pricing will depend on ...

    45 Minutes Later
+20 Other Responses
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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.

  1. Profile Picture

    Dov |Director, VP

    What is the commitment in terms of hours and travel? My availability is limited to a few hours a we...

    2 Hours Later
  2. Profile Picture

    Hrishikesh |VP of R&D and Manufacturing

    I would be more than happy to be the "hands-on doer". I have been through two De Novo submissions re...

    2 Hours Later
  3. Profile Picture

    Susan |President and Founder

    I have over 20 years experience and have submitted many 510ks. The largest was 8000 pages and I am e...

    2.3 Hours Later
+32 Other Responses
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Fda 510k

Looking for a seasoned 510k submission expert with significant proven experience with ivds. - need someone with experience in the gastrointestinal space, medical devices and colonoscopy.

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    Ronald |CEO & President

    I have over 40 years experience filing 510K paperwork. If you want t discuss this project, I don't c...

    1 Hour Later
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    Rui |Assay Development Director

    Hi, I was working with quality and *****rtments on Cardiac and Sepsis bio-markers FDA 510K...

    4.2 Days Later
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    Stephane |Principal

    Hi, My consulting company can help you with your *****s. I have significant experience ...

    5.1 Days Later
+7 Other Responses
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Fda 510k Filing

I need an independent consultant to file substantial equivalence 510 k with fda

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    Polina |Oversight & Monitoring Lead, Health Care

    I support 510K fillings for drug products. Email me at ***** ...

    1.6 Hours Later
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    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
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    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
+31 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.

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    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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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.

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    John E. |Principal; Member-Manager

    Infrared *****ces are Class II. Would depend on claims and ***** heat source and applica...

    19.2 Hours Later
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    Courtland |CEO

    Please contact me for your quick response to your questions. I have over 30 years of experience in ...

    19.4 Hours Later
  3. Profile Picture

    John |Principal Consultant, Owner

    Dear Inquirer: I have over 30 years of experience in the medical device field and filed my first 51...

    19.7 Hours Later
+46 Other Responses
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Medical Device Labeling And Compliance

Looking for a subject matter regulatory expert for fda 510k medical device labeling on pouches, secondary packaging, primary packaging and dfu requirements. Need to review labels and content.

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    David |Sr. Product Development Consultant/Owner

    I use to run the med device label group for Hospira. I can help you with all your requirements inclu...

    1.4 Hours Later
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    Monther |President

    Hi, I'll be glad to assist you with the device and accessory labeling. The labeling requirement docu...

    2.3 Hours Later
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    Courtland |CEO

    I have 32 years of experience and have a young man that is one of 5 globally that submits labels to ...

    5.5 Hours Later
+11 Other Responses
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Fda 510k

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

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    James |CEO

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

    8 Minutes Later
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    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
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    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
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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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    Courtland |CEO

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

    9.3 Days Later
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    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
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