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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.
  2. 2. Within a day or two typically 6 - 12 Experts, who have opted-in, will contact you with a brief explanation of their qualifications and how they can help.
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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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    Monther |President

    Hi, I'll be glad to assist you with all your *****irs tasks/activities. I have over 20 yea...

    4.2 Hours Later
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    Sharon |Principal Consultant

    Attached please my resume for your review and consideration. Please contact me to discuss this caree...

    7.9 Hours Later
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    RONOC IP |Owner

    Resume attached...

    19.3 Hours Later
+25 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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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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Implantable Device Oem Market

We are looking for multiple experts who can talk about technology that interfaces with implantable devices to control the implant, track data, and/or be a two-way channel to review and react data from the device. We are interested in individuals who can discuss about device product or engineering of medical devices original equipment manufacturer (oem) seeking food and drug administration (fda) approval. This is a paid 1-hour phone consultation. Please provide a brief answer as to your relevance to the space below: 1. Are you able about speak about the market growth or development of internet of healthcare things (ioht) for devices interfacing with implantable devices? 2. Can you speak about specific use cases of this technology and how it is likely to evolve in the market? 3. Can you speak about the landscape of different types of technology providers in this space?

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    Roy |President & CEO

    To address your questions: 1. Yes, I can speak to market growth for interfaces to implantable device...

    1.6 Hours Later
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    John |Consulting Engineer

    Though I'm not current w/FDA ***** I can provide aid in product design and implementation s...

    1.9 Hours Later
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    Daniel |Product Management and Strategy

    Rate 500 As the current director of Digital health for Samsung I'm knowledgeable about IOHT and imp...

    18.9 Hours Later
+5 Other Responses
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Implantable Device On Telecom Channels

We are looking for multiple experts who can talk about technology that interfaces with implantable devices to control the implant, track data, and/or be a two-way channel to review and react data from the device. We are interested in individuals from the heatlhcare buying groups who can discuss the factors to consider in deciding the technology and the medical device original equipment manufacturer (oem to partner with. This is a paid 1-hour phone consultation. Please provide a brief answer as to your relevance to the space below: 1. Are you able to speak about the fda approval process specific to the security protocol relevant to the technology for data management that interface with implantable devices? 2. Can you discuss the outlook for these types of devices? 3. Are you part of the decision-making team in choosing the technology and medical device original equipment manufacturer (oem to partner with?

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    Ben |Expert

    This is fairly straight forward. And this is not new. The first technology was really ankle bracel...

    3.9 Hours Later
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    Ray |Vice President, Legal, General Counsel a

    Dear Sir/Madam: Thanks for the inquiry but I really do not have any experience regarding this subjec...

    13.5 Hours Later
+3 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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Online Pharmaceutical & Medical Devices Market

Need an expert who would be able to assist on the global online pharmaceutical and medical devices market. The key data points that i would like to discuss our: - evolution of the online sales of pharma and med devices - key driving factors and challenges - split of offline and online share pharma and med devices - geographic split of the online market of pharma and med devices - operating model of companies - type of products sold via the online channel - split on type of customers purchasing via the online channel (b2c, b2b) - future landscape of the online channel we need to understand the global perspective on the study.

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    John |Director of anesthesia

    Hi I founded iPill Dispenser a medical device going through a FDA ***** then FDS approv...

    2.1 Hours Later
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    Polina |Oversight & Monitoring Lead, Health Care

    I can discuss this topic in depth and can discuss each of your topics and focus areas below....

    2.1 Hours Later
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    Mohamed |Clinical Research/ External Contractor

    I need more specific *****t products sales target audience. I have established several ...

    2.2 Hours Later
+29 Other Responses
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Combination Medical Devices

We are using a new api as an active ingredient in a coating formulation to be applied to a wide variety of medical devices. The api elutes out slowly over time. Looking to find an expert with tox and regulatory knowledge on combination medical devices (device/drug) spanning many different fields of use: dermatology, vascular access, respiratory, orthopedic and others.

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    Courtland |CEO

    We have excellent knowledge in pharma and device. Please let us know if we can help you. We only h...

    2.2 Hours Later
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    B |abc

    Dear Inquirer: am a professional with more than 10 years of experience in biotechnology and life s...

    2.5 Hours Later
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    John |Director of anesthesia

    Hi As an anesthesiologist I started a pharmacetical company to develop a safer opioid that minimize...

    2.7 Hours Later
+16 Other Responses
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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.

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    David |CEO

    I have done both - I've established a complete ISO***** QS and written, submitted and gotten product...

    14.9 Days Later
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    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
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    John |Founder and Managing Director

    SUMMARY ***** practical professional with extensive VP/Director level experience. Expertise i...

    14.9 Days Later
+20 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 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 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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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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