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  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.
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Recent Medical Devices Inquiries

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Medical Device Regulatory Affairs & Quality Assurance

To plan, file, and prepare regulatory, and 510k submissions for fda on new or substantially changed products. In addition the incumbent will prepare technical files in support of ce marking, and maintain compliance with applicable device regulations including support of fda udi requirements. Finally the incumbent will serve as regulatory representative on selected project teams for new product design as well as project teams for process development, developing departmental sops/policies regarding regulatory requirements and processes. Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting. Competitive salary and benefits. Relocation offered. Job responsibilities: manage daily activities of regulatory affairs and quality assurance personnel implement all regulatory and quality assurance activities according to in-house procedures and regulatory requirements establish qa procedures for internal and vendor compliance with the fda and international regulatory requirements, quality regulations and guidelines communicate with regulatory agencies; provide oversight to ensure that the company is 100% compliant with us and international regulatory requirements lead regulatory affairs and quality assurance during fda inspections, notified body audits and internal audits; participate in all respective agency audits and responses to support audit findings or other respective actions related to such audits determine the types of regulatory submissions or internal documentation that are required, in situations such as proposed device changes, and maintain regulatory clearances and approvals with necessary filings and communications prepare fda premarket submissions (including fda 510k) and technical files as required for new and updated products qualifications: **must haves** bachelor’s degree in a scientific or engineering field or equivalent combination of experience. Minimum of 5 years working in the medical device industry within regulatory affairs role is required. Must have direct, lead role fda/iso audit experience must have proven ability to prepare and submit documents to fda, such as 510(k) premarket notifications, investigational device exemptions (ides), and premarket approval applications, (pmas); must have proven successful ce marking of devices through design dossier or technical file process. Location: greater philadelphia area, pa

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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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      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

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        Courtland |CEO

        Jasmine, Our team has a wound care expert. 33 years experience. Many submissions and product deve...

        4.8 Hours Later
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        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
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        Michael |Regulatory Project Manager

        Hi Jasmine, *****irs Associates (RAA) has successfully submitted over 200 medical device s...

        5.1 Hours Later
      +13 Other Responses
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      Medical Device Software Validation

      Simple pressure monitoring medical device which needs outsourced software validation work to support fda 510(k) filing. Only about 600 lines of code.

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        Joe |Business Development Professional contact tony raymond via linkedin in *****on area...

        12 Minutes Later
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        Cartik |Imaging Principal

        I could help with software validation. I have 8-10 years of experience in software ***** FD...

        26 Minutes Later
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        Anil |Director (Digital Marketing (SEO, SMO, P

        I can do it. I have ***** Bio Medical Instrumentation. I have 1.5 decades of IT experien...

        26 Minutes Later
      +9 Other Responses
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      Total Hip Implant Medical Device Failure

      I have a case against djo llc involving the failure of a total hip implant medical device. Need a medical device biomaterials engineer with medical device design/failure analysis experience.

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        Arun |Chief Scientist Neuracon Biotech Inc

        I have experince in biomedical implants, ***** medical device design let me know Thanks...

        7 Minutes Later
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        Ted |Owner

        I have opined on many cases ***** *****opedic device failures. The majority of th...

        8 Minutes Later
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        Jonas |Senior Scientist

        How can I help? I have been an expert witness, have performed biomedical analysis work and, as I pre...

        11 Minutes Later
      +10 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 Device Distribution License

      I am interested in a medical device distribution license which will allow me to sell class 1 or 2 medical devices

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        Howard |General Manager

        I have run several DME manufacturing companies over the past 15 years and have been involved with li...

        50 Minutes Later
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        Eric |Partner

        Great, I have over ten years experience in drafting medical device distribution agreements in the US...

        1.1 Hours Later
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        Uwe |CEO

        We are delighted to send more *****d you please ***** company and address and we...

        15.7 Hours Later
      +5 Other Responses
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      Fda 510k

      Hello, i'm looking for a consultant to assist with an fda 510k submission for a: class ii ophthalmic medical device if you have expertise in this area, please let me know. Thank you.

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        Les |Principal

        I have more than 40 years in the *****stries and have successfully submitted numerous 5...

        1 Minute Later
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        Mark |Clinical Associate Professor, Oregon Hea

        I have helped many companies achieve 510k clearance for ophthalmic devices, from imaging systems to ...

        4 Minutes Later
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        LAWRENCE |President and Ph D

        Please see my profile. I have worked as VP for a major company for contact lenses. I have been consu...

        6 Minutes Later
      +24 Other Responses
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      Medical Device Fundraising

      I am looking to raise $3 million to start initial test on a new ceramic nanocoating stent. Although our first priority is to develop the cardiac stent, we do plan to use the coating in a variety of other medical device applications including implantable catheters, surgical instruments, and brain stents to name a few. Briefly, we are seeking funding to complete in-vitro and in-vivo studies. Recent meetings with the two leading cardiac stent manufactures concluded that the negotiations would commence once we have initial results in 2-3 months and progress from that point leading to a buyout or licensing agreement. Finally, because of the uniqueness of our nanoceramic cardiac stent, it is anticipated that the nanoflex™ stent will significantly penetrate the projected $9.7 billion dollar 2017 cardiac stent market. Complete prospectus documents are available for your review on your request.

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        Vanesa |Development Engineer/ Medical Science Au

        Hello. I have 6 years experience working with stents (Johnson and Johnson) and over 10 years in medi...

        4.8 Hours Later
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        mark |President

        I am on the Board of a respected Contract ***** this space we could certainly assist you i...

        2.9 Days Later
      +3 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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      Medical Device Supply

      As the owner and developer of a proposed (to be new up-scale medical hospital -we are requesting - only experienced medical equipment suppliers to provided a listing major hospital medical equipment (electronic) "new" for a 350 room hospital along with medical device mongering - for all major illness - cancer, mri (2), cat scan, neck, breast, part- eye, ear nose heart, ect - our out patient clinic and re-hab center are all to be - equipped with the newest state of the art equipment - - with cancer treatment center is essential - additionally - our dental department will be staff with 8-10 stations - (doctors - all separate chairs - along wit h a lab for impression -

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        Paul |CEO

        Not my area of expertise....

        6.1 Hours Later
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        Meg |Founder / President

        Thank you for reaching out. This is not my area of expertise directly....

        13.3 Hours Later
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        Rajkumar |Zintro Expert

        hi , Very good morning,we are good in the reach of institution of africa ,we shall have a telecon ac...

        16.3 Hours Later
      +12 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
      See More Inquiries

      A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).

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