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Recent Fda Approval Inquiries

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Fda Approval For Medical Technology

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 work or have worked recently at the food and drug administration (fda) or fda-approval consulting firms who help companies seek fda approval for technology (i.E., hardware, software, and operating systems). 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. Do you have direct experience assessing purpose-built devices that have sought fda approval? 3. Are you able to speak about the different views of the fda between purpose built-devices and software for bring-your-own-device (byod) equivalents?

  1. Profile Picture

    Asad |Zintro Expert

    Yes I can help....

    40 Minutes Later
  2. Profile Picture

    William |VP, Regulatory, Clinical and Compliance

    1. Are you able to speak about the FDA approval process specific to the security protocol relevant t...

    58 Minutes Later
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    John E. |Principal; Member-Manager

    1. Are you able to speak about the FDA approval process specific to the security protocol relevant t...

    2.2 Hours Later
+13 Other Responses
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Fda Approval Process

I am in the process of partnering up with a design/manufacturing facility to get my device to a design freeze and subsequently through all the processes to fda approval via 510k filing. I am in need of a consultant just to guide me through the process and help me out with this collaboration to ensure i do not make any mistakes when dealing with such a company.

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    Andrea |Principal Consultant

    My hourly rate....

    45 Minutes Later
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    Fayyaz |Managing Partner

    Hi, I have signficant experience in this area and will be happy to help. You can reach me at *****...

    46 Minutes Later
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    Jim |Principal

    I'd be happy to help!...

    1.3 Hours Later
+18 Other Responses
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Fda Approval

I have a product which is a gel that treats wounds, burns, and type 2 diabetic cracked skin. This has a ec mark in europe and is a 2b medical device. I have all of the microbiology reports and would like to know how to proceed towards fda approval. The product is completely natural and is comprised of oxygen and seawater. I also saw there was a no classification option under fda under wound kit without drugs. This would be excellent for both otc as well as hospitals. Can someone please tell me how to proceed.

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    Les |Principal

    I can help you with this project. Wound care products are considered (usually) medical devices in t...

    7 Minutes Later
  2. Profile Picture

    Timothy |Principal

    I am a former FDA Review Chemist who served in the Office of Generic Drugs specifically in the revie...

    16 Minutes Later
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    Jack |President

    I have experience in Drugs, OTC, Medical Devices and Cosmetics. One would need to know more about t...

    1 Hour Later
+13 Other Responses
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Otc Product Approval Us

We are launching a new iron supplement in the us and require someone to provide regulatory affairs advice on the fda approval pathway for the product. 

  1. Profile Picture

    Parul |Regulatory Consultant, Elexes Inc.

    Thank you for the inquiry! I would love to help you on this! I run a small *****ice firm...

    12.5 Hours Later
  2. Profile Picture

    Rajib |Manager

    Hi ,This is Rajib and i am a *****irs Pharmacist.I have five years of experience in Drug R...

    12.7 Hours 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...

    13.9 Hours Later
+12 Other Responses
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Ce And Fda Approval

New medical device company seeking regulatory medical device expert for ce and fda approval process. Prefer regulatory experience with extracorporeal devices including dialysis and apheresis filter technologies.

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    Mercedes |Principal Consultant

    I have over 30 years of experience in medical devices, a good portion of that with hemodialysis mach...

    12.8 Hours Later
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    Denise |

    Happy to help you out. Expert in CE mark and FDA submissions and approvals. Specialize in medical de...

    12.8 Hours Later
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    Denise |Senior Consultant

    Our company specializes in medtech *****tegy in the US and Europe. Excellent track record ...

    12.9 Hours Later
+37 Other Responses
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Skin Mask Fda Approval

I am importing a product from overseas into the u.S. It is a skin mask made from volcanic clay (kaolin) and water (sole ingredients). I am doing due diligence to determine 1) whether this product requires fda approval or any lab tests done; and 2) labeling requirements. Thank you.

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    DENNIS |Partner

    the product will require a Challenge Test (Microbiological Determination). For labelling requirement...

    37 Minutes Later
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    Jonathan |Principal

    Microbial (Total and Objectionable) a well as "label" claims....

    37 Minutes Later
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    Evelyn |Owner & Principal Consultant

    Based on the ingredients and your brief description, the product would likely be classified as a cos...

    41 Minutes Later
+11 Other Responses
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Fda Compliance

I am looking for speaker/consultants form fda compliance industry who are ex fda's . Please drop me a message if this is suitable & this is for engagement in 2015 .

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    Timothy |Principal

    I am former FDA and as a consultant for 18 + years I have furnished clients with quality system audi...

    5.2 Days Later
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    Mithilesh |Freelance Consultant

    I am not from FDA. However, have more than 30 years experience in Pharma Sector & presently working...

    5.7 Days Later
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    Balvant P |President

    I have a proven expertise / experience in the overall areas of Quality (QA/QC) / FDA's GxP Complian...

    5.8 Days Later
+5 Other Responses
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Medical Device Fda Approval

Looking to get dental xray sensor fda approved

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    Daniel |CEO & President

    Hello. We would be happy to help you. within our consulting group we have an FDA and QMS expert. Ple...

    1.4 Days Later
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    Cartik |Medical Device, Practice Lead

    I have experience with fda approval and orthodontic devices. I could help you obtain the FDA approva...

    1.6 Days Later
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    Kevin |President

    I have a great deal of experience in digital imaging technology for medical *****. I would be...

    8.3 Days Later
+10 Other Responses
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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 Approval

Hi, i want a product tested for fda approval

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    David |Director of Quality Assurance

    Can you please ***** the project?...

    48 Minutes Later
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    Alan |President and Senior Consultant

    I will be happy to use on your behalf my experience and expertise in having products tested to meet ...

    48 Minutes Later
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    steve |ceo

    Hi , Happy to help. Please contact me so we can discuss what testing needs to be done for the approv...

    50 Minutes Later
+18 Other Responses
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Fda Compliance

Dear sir i am a quality assurance manager of one of the biggest pharmaceutical company in turkey. I am looking for a fda compliance consulting company to assist us for fda approval process.

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    Cynthia |Executive Vice-President

    Please allow this note to introduce my company, American Technical Consultants to you. I am sure we...

    5 Minutes Later
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    Anastasia |Consultant-Microbiologist

    Is this for a sterile drug, solid dosage form, generic or brand name, biotech or small molecule? I c...

    9 Minutes Later
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    Maha |Senior Consultant

    Dear Sir, I believe I can help you. I am a consultant with extensive experience with the FDA approva...

    1.5 Hours Later
+19 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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