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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 Supplies And Devices Inquiries

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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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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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Fda Approval For Medical Device

Mechanical facial stimulation on the skins surface.Natural. Targeted cellular response and lifting effect. Non invasive non agressive.

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    Byron |President/Consultant

    I am.confident that either myself or someone else from our company can help you. Your first step wil...

    13 Minutes Later
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    Diane |Sr RA/QA Consultant

    Have many years experience with FDA submissions, including medical device. Former reviewer with exp...

    21 Minutes Later
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    Rita |Principle

    Dear FDA-7YtQ3F, I would be more than happy to help you with this project. I would need some addit...

    5.9 Hours Later
+4 Other Responses
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Design And Prototyping Of Medical Devices

Position description: lead – ortho neuro spine department: r&d lead – ortho neuro spine will be responsible to develop strong talent to grow recon business that includes hips and knee, trauma, spine and navigation. Person will develop strong r&d infrastructure to manufacture, design, prototype, develop products for ortho neuro spine business. Person will also be responsible to develop strong process for development of medical device. Key responsibilities: • develop products and build strong teams • to ensure having the right quality systems compliant to 21cfr820, iso13485 and iec62304 • will be responsible to hire the right talent, build a strong team and engage the team • work closely with us r&d leaders to develop product pipelines and create product roadmap • collaborate with sales & marketing to develop product roadmap • work closely with support groups like ra/qa, finance and hr • lead a team of 50 – 100 people • to ensure timely deliverables to our internal customers position description: lead – hospital infrastructure department: r&d lead – hospital infrastructure will be responsible to develop strong talent to grow hospital infrastructure business that includes patient care and handling and operating room -suite product lines. . person will develop strong r&d infrastructure to manufacture, design, prototype, develop products for hospital infrastructure business. Person will also be responsible to develop strong process for development of medical device. Key responsibilities: • develop products and build strong teams • to ensure having the right quality systems compliant to 21cfr820, iso13485 and iec62304 • will be responsible to hire the right talent, build a strong team and engage the team • work closely with us r&d leaders to develop product pipelines and create product roadmap • collaborate with sales & marketing to develop product roadmap • work closely with support groups like ra/qa, finance and hr • lead a team of 50 –75 people • to ensure timely deliverables to our internal customers • capable of ‘thinking outside the box' • proven experience as a project lead/ manager with good supervisory and team work skills in a fast paced/dynamic environment. • have worked on r&d for operating room devices e.G. Surgical lights, video management, tele medicine, beds and stretchers

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    John |CEO

    Please contact me with this inquiry. I would consider helping your company after learning more about...

    11.9 Hours Later
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    Ade |CEO

    Hi Sheetal Thanks for the enquiry but this is not in my field of expertise. Regards Ade...

    23.8 Days Later
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    Benjamin |President/CEO

    Are you searching for an engineer or a more sales and marketing focused candidate?...

    30.1 Days Later
+3 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 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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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 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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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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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 Project

We are a rapidly growing, leader in end-to-end optical design and manufacturing solutions for global medical oem’s. Covering areas such as endoscopic imaging systems, robotic imaging systems, 3d, disposable and miniature imaging systems, endoscope test equipment, and video coupling optics. We are focused on taking the imaging needs of the surgical community and providing superior products and solutions to meet those needs. We leverage our 100+ years of optics expertise and application knowledge to complete projects where time and budgets are critical. Our maine-based based 17,000 sq. Ft. Headquarters includes an fda registered medical manufacturing facility that has been designed to take our customers’ ideas from concept through to high volume production. Our world-class optics laboratory includes a complete optical assembly area, fiberoptics fabrication facility and prototype machine shop. Open positions: we have immediate openings for a project manager (and a program manager). The project manager organizes and coordinates projects throughout the product development lifecycle. The position supports and facilitates business development efforts by employing efficient strategies and tactics that ensure projects deliver desirable outcomes for the organization. Project manager responsibilities . Manage designated projects · partner with technical lead · formulate, organize and monitor inter-connected projects · develop and control schedules, budgets, and activities · analyze and provide guidance on resource loading and allocation to lead program manager · prepare reports, projections, and business intelligence for lead program manager · develop and prepare proposals to facilitate new business · remove barriers and enable success for engineering team project manager experience · medical device development · in depth knowledge of design control process and navigation of projects through process · understanding of quality control systems, iso 13485, iec 60601, and fda medical device regulations · success in execution of complex projects through commercialization · knowledge of relevant manufacturing processes and materials we also would consider candidates qualified for a program manager position.

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    John |Consulting Engineer

    I’m interested in your company both for the position posted and as a company that may be appropriate...

    1.6 Hours Later
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    Steve |Director of Supply Chain, Strategic Sour

    I'm a director of supply chain with more than 12 years experience in the medical device industry. Pl...

    1.7 Hours Later
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    Reza |President/CEO

    Hi, I am a Medical Imaging Consultant and would be delighted to engage on a need basis. You can c...

    2 Hours Later
+112 Other Responses
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