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Recent 510k Inquiries

Fda 510k

We are looking for us-based consultant who can help us conduct a review of our current 510k, evaluate the need for a supplemental 510k given the incremental changes since 2016 release. -develop plan and outline of work required for supplemental 510k -gather required documentation and submit to fda -remediate questions until completion. To qualify, please provide your feedback on the following: 1. Describe your experience with 510k submissions. 2. Describe key parts of a 510k submission 3. What challenges have 510ks presented you in the past? How did you overcome them? 4. What device class (i,ii,iii) does your experience include?

Rob |President / Consultant
Our firm routinely reviews device ***** the need to resubmit a 510(k). Our letter to fil...
40 Minutes Later
Marie |Regulatory compliance/Quality System/ASQ
Hello: I can definitely assist with your 510K review and complete any required amendments in an eff...
46 Minutes Later
Monther |President
Hi, I’ll be glad to assist you in: -Reviewing current product compliance status -Create a plan for ...
49 Minutes Later

+26 Other Responses

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.

Daniel |Clinical Scientist, Regulatory Affairs C
Dear Mr./Mrs: Is this project for work as FDA reviewer? Regards Daniel Ramirez ...
16 Minutes Later
Cynthia |Regulatory Affairs Consultant
I am an independent medical device *****ultant specializing in class I and II medical devi...
21 Minutes Later
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

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

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
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
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

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.

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
Rui |Assay Development Director
Hi, I was working with quality and *****rtments on Cardiac and Sepsis bio-markers FDA 510K...
4.2 Days Later
Stephane |Principal
Hi, My consulting company can help you with your *****s. I have significant experience ...
5.1 Days Later

+7 Other Responses

Fda 510k

We're looking for a remote fda 510k consultant who can help us with medical device 510k submission advice and iso13485 certification. In terms of requirements, we're already taking on board advice to help us get through regulatory hurdles with the tga and ce marks and are fully aware of our requirements and on the way to getting our technical file ready. Our devices are class 2 devices: -a device which converts any bed into a hospital bed (with motors and a frame that adapts to your current bed) -one which monitors movement patterns and vital signs non invasively, as you lay on it. Our app takes in inputs from this, and, perhaps, in the future, other devices too and processes them into alerts that are sent out to loved ones/caretakers. Both are a fraction of the price of current offerings, and aimed at a b2c market. To qualify, please provide your feedback on the following. -have you worked with fda 510k submission in the past? -have you worked on ce marks/tga and other regulatory bodies globally too.

David |CEO
I have done both - I've established a complete ISO***** QS and written, submitted and gotten product...
14.9 Days Later
William |VP, Regulatory, Clinical and Compliance
Yes, I was trained by the FDA on How to Review 510(k's), brought TUV PS now Sud to the FDA to be the...
14.9 Days Later
John |Founder and Managing Director
SUMMARY ***** practical professional with extensive VP/Director level experience. Expertise i...
14.9 Days Later

+20 Other Responses

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.

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
steve |ceo
HI, Happy to get your *****red through the 510k process. I and my small team have gotten ...
25 Minutes Later
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

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

Courtland |CEO
Jasmine, Our team has a wound care expert. 33 years experience. Many submissions and product deve...
4.8 Hours Later
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
Michael |Regulatory Project Manager
Hi Jasmine, *****irs Associates (RAA) has successfully submitted over 200 medical device s...
5.1 Hours Later

+13 Other Responses

Fda 510k

I need someone to write a fda 510k for a class ii product.

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
Andrea |Principal Consultant
Good Afternoon, I have about 20 years of experience in medical device *****irs, I can wri...
4.7 Hours Later
Paul |CEO and Co-Founder
Please contact our in-house *****irs expert, Rich Anderson at (916) *****....
4.8 Hours Later

+24 Other Responses

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.

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
Cynthia |Regulatory Affairs Consultant
Hello, I am an independent consultant specializing in class II 510(k) submissions. Please contact m...
6.3 Hours Later
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

Fda Medical Device

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

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
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
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

Fda 510k

A company that makes personal lubricant class ii medical device is looking for consultants with personal lubricant 510k submission experience

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
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
Diane |Sr. RA/QA 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

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

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

+51 Other Responses

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