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Recent Medical License Defense Inquiries

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Medical Device Classification

I have developed a self defense hand gun intended for seniors and disabled. It was initially classified by the fda as a medical device. I may need assistence in formally rearguing the matter.

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    Chris |Senior Software Engineer

    I've written 510k *****issions to FDA for medical devices for Spacelabs Medical, hardware ...

    1 Minute Later
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    Georganne |Consultant

    What an interesting product! I have been a *****essional for over 37 years dealing with a...

    2.2 Hours Later
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    Jonathan |Principal

    I have a number of resources at my firm who have a wide variety of experience in the medical device ...

    1 Day Later
+10 Other Responses
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Medical Devices

Which of the disposable medical devices has the highest profit margin?

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    Ted |Owner

    I have some experience with disposable peripherals used with several products I designed for world w...

    39 Minutes Later
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    John |Consultant & Executive

    I think I can give you a good sense of profit margins. Feel free to contact me. John Stengrevics...

    42 Minutes Later
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    Ron |Director, Clinical Marketing

    20 years experience both buying and selling disposables. I'd be delighted to help......

    1.2 Days Later
+5 Other Responses
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Medical Device Registration In Argentina

1. Can you please provide a list of requirements for medical device (health canada class ii & iv) registration in argentina? 2. Is it possible for a canadian company to hold the registration license under their name in argentina? 3. If we cannot hold the license in our name, and we want to change/replace the license holder, do we need to reapply? Please explain the process of replacement of license holder (if applicable). 4. We have contract manufacturers overseas who make our products, but we are the legal manufacturers. Do the free sale certificates have to demonstrate product codes from the contract manufacturer or the legal manufacturer (since our codes are different from the contract manufacturer)? Or, do we have to provide a notarized letter demonstrating equivalency of our product codes to the contract manufacturers codes for each product? (our free sale certificate contains only our product codes). 5. Is the health canada export certificate acceptable in argentina (it does not state our contract manufacturers details)?

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    Medical Device Manufacturer

    Looking for medical device manufacturers in michigan, ohio, wisconsin, minneapolis

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      Ronald |President

      What type of capabilities do they need to have? Plastics Molding? Silicone Molding? Metal Fabricatin...

      24 Minutes Later
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      Len |Consultant

      I currently provide engineering and *****ulting to medical device companies as well as con...

      36 Minutes Later
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      Ali |DFSS MBB

      What do you exactly need?...

      3.1 Hours Later
    +5 Other Responses
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    Medical Device Design Quality Engineer

    Position: design quality engineer and manager location: hudson, wi qualifications - education & experience bachelor degree in an engineering discipline or equivalent experience, per engineering criteria matrix minimum six (6) years quality/regulatory experience minimum three (3) years design engineering quality experienceteam-centric design experienceasq certification preferred responsibilities -manage acceptance of product and deliverables from the design process including dhf and engineering project file documents (protocols and reports). -manage the design validation and process validation activities for the development program -contribute to the design and development of components, assemblies and devices for various industries, including medical, defense and industrial -take responsibility for the risk management process, including the subordinate activities and manage the comprehensive risk management file for the development program. -participate on development teams representing quality -provide engineering team with information and analysis tools as needed -lead and coordinate quality system audits - both internal and external -implement systems and procedures compliant with iso 13485 -coordinate new process techniques that improve overall job efficiencies -participate actively in annual business planning efforts including establishing key performance measures, means of data collection, and reporting -development and implementation of statistical incoming and in-process sampling/control plans -manage the qualification of processes performed by company suppliers; troubleshoot and lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections -implement systems and procedures compliant with iso 13485 -coordinate new process techniques that improve overall job efficiencies -develop and manage qualified qa/qc team. Evaluate performance and recommend recognition and reward in accordance with established procedures -responsible for being a communication liaison between the customer and manufacturing facility -extended travel to other facilities may be required to support business needssome programs may have vision requirementsother duties as assigned -provide leadership to the design quality team -serve as the a mentor to the junior design quality engineers -actively participate in the building of the design quality team -represent the design quality team in new product introductions, and serve as the design control subject matter expert (sme) for the facility. -complete performance evaluations and communicate performance standards and results with the worker qualifications - skills & competencies -understanding of design and development processes, associated terminology, and iso 9001-2000, iso 13485, and fda regulated product quality requirements. -ability to effectively present information and respond to questions from managers, sales personnel, and customers -strong communication (verbal and written), teamwork and organizational skills -ability to identify problems, and develop and implement actions to resolve them -ability to motivate and influence people to achieve compliance to requirements -demonstrable track record of project accomplishment -demonstrable track record of planning activities with contingency actions

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      Edward |President

      Staff: The following represents a high-level summary of specific experience and ***** I hav...

      9.8 Days Later
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      New |

      jkjdskfjldjwkflkj...

      10.9 Days Later
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      New |

      Sandeep Kumar Narra, 700 W Mitchell Circle, Apt no 615, Arlington, TX *****. Dear Sir/Madam, Pleas...

      12.9 Days Later
    +17 Other Responses
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    Ceo And Board Members For A Medical Device Company

    Repost -- mdb is an authorized zintro partner. Mdb is looking for a ceo and three board members for one of its new start-ups called electroblate, inc. Can you help us fill these positions? If your referral for the ceo position is hired you will earn a reward of $20,000. If your referral for a board position is appointed you will earn $10,000. Note: you are welcome to apply for the positions, but are not eligible for a referral fee for referring yourself. Here is how it works: 1. Submit the candidates (or apply) via the following links: - ceo position: http://bit.Ly/1rxtd43 - board position(s): http://bit.Ly/1wrhraj 2. Within one week you will receive feedback and you will be kept up to date with the progress. Here is a brief description of electroblate and you can learn more by clicking on the links provided above. Electroblate, inc. Is a clinical-stage, medical device company developing a unique platform to induce programmed cell death (apoptosis) in soft tissue non-thermally. By inducing apoptosis the body doesn't recognize injury and repairs the treated tissue with normal tissue in the treated area. The applicable worldwide market, exceeds $15 billion, and targets multiple therapeutic applications, such as tumor/cyst/unwanted tissue ablation, and multiple cosmetic applications. The company is a technology ?Roll-up? Being created by mdb to acquire the operations and ip of three companies and two universities, enabling electroblate a dominant ip position in this technology area. In addition, the principal scientists and inventors are equity holders and will be working with the company to help further the technology platform. Thanks again for your help in our mission of maximizing the probability of success of these disruptive technology companies! best regards, chris

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      Anna |VP, Managing Director

      I am experienced and ***** this role. Please, let me know what ***** that job. I will se...

      1 Minute Later
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      Shashi |Executive Vice President

      I can help. Pls email at ***** call me at *****. Shashi...

      1 Minute Later
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      Bernadette |Director, Consultant

      Hello I am an Advanced Practiced Registered Nurse with fifteen plus years of experience in Managed C...

      1 Minute Later
    +54 Other Responses
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    P And C Insurance Medical Records Retrieval

    One of our clients is seeking to learn about the process of medical records retrieval in the p&c insurance industry. If you work at a p&c insurer or have experience consulting for such an organization - are you familiar with the process of attorneys / litigators using third-party records retrieval firms to retrieve medical records for a p&c insurance case? If so - we would love to discuss next steps.

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      Defense Contract And Brokering

      Good day, i am looking for someone with experience in defense contracts and defense brokering to teach me and help me set up a defense contracting company in the us. Have some connections with some small arms manufacturers and aviation spare part businesses. Have also a network outside the us for garment manufacturing (knits & wovens). Please contact me if interested maybe a joint venture could come out of this. I am basically asking for guidance on how the system works and advice on what would be the best way to start. I am not a manufacturer. I am looking to broker or source & purchase as the core of my business.

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        Ioannis (John) |Consultant

        I'm interested in further discussing you project. Are you looking to export from the US, import int...

        1.5 Hours Later
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        Allen |CEO

        To whom it may concern: I can help you set up this type of ***** and *****. C...

        1.5 Hours Later
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        Kent |Managing Partner

        I have over 25 years experience in all aspects of the Department of Defense procurement process, inc...

        1.6 Hours Later
      +16 Other Responses
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      Medical Device Ceo

      Looking for a medical device ceo in ophthalmology.

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        Medical Diagnostic Laboratory Industry

        We are in the process of potentially pursuing an opportunity in the medical diagnostic laboratory industry. Target business characteristics: · has 400+ tests and serves over 3,000 physician and hospitals · will complete more than 270,000 patient order in 2017 · testing categories include routine testing and esoteric testing o routine testing is predominantly basic blood analysis and accounts for 60% of volume o esoteric testing accounts for 40% of volumes competitive landscape: · heavily consolidated at the top and highly fragment at the bottom o major players include medlabs, labcorp, quest · industry is not driven by price we are looking for an experienced operator and/or industry executive who can give us insights on (i) reimbursement rate environment; (ii) barriers to entry; (iii) industry success factors; (iv) dynamic between hospital completing testing in-house vs outsourcing; and (v) any upcoming legislation that may significant impact the industry.

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          Medical Disposable Syringe Project

          Hi sir this is raja from andhrapradesh, india. I want to start a medical disposal syringe unit . For this purpose may i know details about invest amount and how to get machinery details and market potential and all .Is there any consultancy services which is offers services? Please inform me the full details about this project thank you sir.

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            Joseph | ----------------Director---------------

            Zib5e448 Here are initial generic proposals on a direct labor control system that offers up to 40% ...

            1.5 Hours Later
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            Tarun |Partner

            Hi Raja, I can help you n this, we are based out of Mumbai and have relevant expertise. Regards, ...

            14.1 Hours Later
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            A K |Zintro Expert

            contact ***** A K Singh...

            17.1 Hours Later
          +6 Other Responses
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          Medical Device Quality

          I need a medtech/medical devices expert with a strong history in quality management for manufacturing and operations. Ideally this expert will have a strong understanding of these manufacturing processes, including things like the expected contaminant levels and tolerances in a clean room, etc. The expert would ideally be located in either south california or the east coast (baltimore would be ideal).

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