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Recent Medical Device Regulations Inquiries

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Disposable Medical Supplies Fda Approval

Hello. We are a new company looking to bring disposable medical supplies from china to the usa. We are focusing on a small number of products initially. The manufactures we are looking to work with are based in china and have fda certification themselves but from what i have learnt we also have to apply for fda approval, we will be re-branding the products and importing. We are unsure as to what we need to do to ensure our products are compliant and what paper work/fees are required and would be grateful for any advice/guidance you may have. Kind regards dr chauhan

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    Steven |Owner

    I recently organized single use equipment, volumes, reactors, filter systems for a biotech project s...

    14.7 Hours Later
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    Dr Venkat |Global Consultant

    Dear Dr Chuahan, I can assist you n this and can arrange support from current as well as Ex FDA Insp...

    14.9 Hours Later
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    John E. |Principal; Member-Manager

    You will have to register w the US FDA and pay an annual fee. You will have to come under parts of t...

    15.5 Hours Later
+13 Other Responses
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Fda Medical Device

We are in search of an expert witness who can evaluate whether a medical device company complied with fda regulations in validating products before shipping for commercial use. Former fda auditor preferred.

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    Les |Principal

    I can absolutely help you. Please check my website, www.quality-docs.org to view my credentials. P...

    7 Minutes Later
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    Shailesh |Practice Manager

    Hi there, I can help you in this area. I work with a company which provides this service. Kindly l...

    11 Minutes Later
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    Timothy |Principal

    I am former FDA, engage in device and drug/device *****tegy, perform device Quality System...

    13 Minutes Later
+14 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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Medical Devices Product Launch

I am looking for an expert to support the launch of a new product in europe in 3q 2012. The competitive candidate will have demonstrated expertise in international trade, customs, supply chain, logistics, distribution and insurance for class ii & iii fda/ema medical devices.

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    David |President and CEO

    Please let me help you I have over 150 510k to my credit, PMA and *****se contact me ...

    13 Minutes Later
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    Aaron |V.P. and General Manager

    Hello, My company supports companies to design and introduce products all over the world and I'm ce...

    38 Minutes Later
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    John |Consultant & Executive

    I think I can help you out. I've had a lot of experience launching medical device products in Europ...

    4.3 Days Later
+8 Other Responses
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Fda And Medical Devices

Hi, this is ranjan from complianceonline (training and coaching) on fda and medical devices. I would like to invite you as a speaker with our company on online webinars. Kindly let me know would you be interested as a speaker/expert and provide trainings. Thanks & regards, ranjan

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    David |Director of Quality Assurance

    I would like to hear more about this project. ...

    15 Minutes Later
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    Mark |Clinical Associate Professor, Oregon Hea

    Hi Ranjan, Yes, I'd be interested. Please forward further information....

    19 Minutes Later
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    Umberto |Previously: COO, VP & Director Regulator

    Dear Ranjan, I would be interested. Sushma has already scheduled a "Discovery Call" meeting on 5/21...

    19 Minutes Later
+33 Other Responses
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Medical Device Fda Approval

Need help with applying for fda approval of medical device. Would like to pursue either a 510k application ( if predicate devise exists) or if not, de novo application

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    Cynthia |Regulatory Affairs Consultant

    Hello, I am an independent *****ultant specializing in class II medical devices. I devel...

    2 Hours Later
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    Andrea |Principal Consultant

    I have written many 510(k)s and some de novo *****ughout my 20 year career as a Regulato...

    2 Hours Later
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    Susan |President and Founder

    I can help you with this project. Please take a look at my background...

    2 Hours Later
+31 Other Responses
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Online Medical Training

Hi all, i am looking for speakers/experts for online training in the below areas: medical device fda compliance pharmaceuticals biotech lab if you are interested, please leave your contact details and convenient time to connect. Best regards, rahul

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    Nicholas |Director R&D

    I have been in the medical device and pharmaceutical industries for over 40 years. Included many e...

    41 Minutes Later
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    Diane |Sr. RA/QA Consultant

    Dr. Diane Sudduth ***** (best time to contact after 4pm EST) Fluent in medical device quality...

    41 Minutes Later
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    David |Industrial support and development

    Hi, I have an extensive experience in medical devices (orthopedic and neurostimulation), both in va...

    42 Minutes Later
+30 Other Responses
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Medical Device Class I

My class one medical devices are being held for fda examination. Imported product from taiwan supplier without a fda registration. Our company is registered. These products are custom made from our specifications and packaged here in seattle. The tariff classification is accessories for wheelchairs. Any idea why we would be under a fda exam or how we can get our products released?

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    Kevin |Principal Consultant

    ComplianceAcuity can help, but we will need more *****ils. Let's talk....

    38 Minutes Later
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    Umberto |Previously: COO, VP & Director Regulator

    Dear Inquirer, I have had a lot of experience in this area. What I can tell you is that FDA regardi...

    2.3 Hours Later
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    John |Owner and Sr. Consultant

    You possibly are under FDA exam because the exporting company does not have an establishment registr...

    2.5 Hours Later
+10 Other Responses
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Fda Medical Device

*******, a class 3 medical device startup company is looking for and experienced chief operating officer with experience of taking a medical device from startup to fda approval.

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    Ron |I have held the following titles, Presid

    I saw your post seeking someone with medical device start-up expertise. I have that experience and w...

    38 Minutes Later
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    Mark |Executive CEO/ GM/ Interim Executive

    Hi, thank you for the inquiry. While I am an experienced COO of start-up(s) and *****-t...

    1.7 Hours Later
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    Michael |Principal Consultant

    What therapeutic focus? I have experience with orthopedics. Mike...

    3.2 Hours Later
+11 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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Medical Device Manufacturing Landscape

Have a potential client that we may do research for. Am trying to get a feel for whether or not we can actually find them the right respondent types. They are looking to speak with key decision makers of medical device manufacturers, specifically looking to speak to them about the following: - identifying pain points, fears, uncertainties, and potential points of confusion that they can address through marketing communications - establishing the audiences that have the most interest in and need for the client's services - what motivates them, where do they get information, etc. - questions/concerns that manufacturers have about entering the chinese market and work with the cfda - general unmet needs or medical device manufacturers as it pertains to better grasping standards set for class ii or iii devices by the cfda, fda, or ema. If there is anyone that feels they might be the right person to speak with for this study, or know what title(s) we should be targeting at the manufacturers, please send me a message. Targeting key decision makers that actually work for a medical device manufacturer thank you!!

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    William |VP, Regulatory, Clinical and Compliance

    See attached two documents, Bill J...

    1 Hour Later
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    Robert |Executive Market Consultant

    I would he happy to speak with your group regarding these questions. *****et entry is ...

    1 Hour Later
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    Jose |Vice President - Regulatory Affairs and

    Hello - all the aspects ***** your request are part of my 17 years in medical devices. All aspec...

    1.4 Hours Later
+17 Other Responses
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Medical Device Manufacturing

I am looking for a business partner to help me commercialize a medical device designed to enhance leg circulation to heal diabetic and other wounds and prevent amputation. An ideal candidate would have an established track record of going thru the entire process, from fund raising, prototype development, fda and cms approvals, and marketing, and be amenable to joining me for an equity share. A person based in the greater phila/southern nj/nyc area is strongly preferred.

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    John |President, Founder

    What is your experience abd background in Wound care and starting a company?...

    12.3 Hours Later
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    Noam |CEO , CTO

    Leader, inventor and entrepreneur ***** the ***** new opportunities and developme...

    36.9 Days Later
+2 Other Responses
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