I will do tech documentation mdr sfda fda ukca tga and amazon devices

5.0
5.0

Pakistan

I speak English

20 orders completed

Regulatory Specialist, Technical Writer, CER Expert, Data Analyst

BROMED a professional team dedicated to delivering high-quality, on-time results. We specialize in regulatory affairs, data analysis, technical writing, and research, preparing CERs, BERs, risk manage...

Level 1

Has met certain performance criteria and shows strong potential in the marketplace.

About this Gig

I am a Regulatory Affairs and Medical Device Consultant, specializing in EU MDR, IVDR, FDA, SFDA, UKCA, and Amazon compliance.

With years of experience in the medical device industry, I offer comprehensive services to ensure your products meet all the necessary regulatory standards. My expertise spans across device registration, clinical evaluations (CER/BER), technical documentation, risk management, and quality management systems (QMS).

Services I provide:

  • Regulatory submission for EU MDR, IVDR, FDA, SFDA, UKCA, and Amazon
  • Complete technical documentation (CER, BER, risk management files)
  • Preparation for market approval and CE/UKCA certification
  • Post-market surveillance and vigilance reporting
  • Compliance with the latest regulations and standards

Whether you're seeking to launch your product in the EU, US, Saudi Arabia, or UK markets, or need to align with Amazon's regulations, I offer tailored solutions that ensure compliance and smooth market access.

Let's work together to navigate the complex regulatory landscape and get your medical devices to market with confidence!

Document type:

Documentation

Regulatory Documents

Industry:

Science

Language:

English

Urdu

Delivery style preference

Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.

My Portfolio

Reviews

4 reviews for this Gig
5.0

(4)
(0)
(0)
(0)
(0)
Rating Breakdown
  • Seller communication level
    5
  • Quality of delivery
    5
  • Value of delivery
    5
Sort By
Most relevant
  • A
    image-docs

    ariankamali

    US

    United States

    5

    He is highly professional and has extensive knowledge in regulatory affairs. Thanks to his expertise, my medical device was successfully registered in EUDAMED and has now received CE approval.

    Up to $50

    Price

    4 days

    Duration

    Helpful?
    Yes
    No
  • D
    image-docs

    dlow128

    GB

    United Kingdom

    5

    We are currently working together on a project here. His knowledge of the processes and standards involved are at a very high level. Some more technical documents to come plus the CER. He is always there to answer any questions and is happy to help. We hope to have a fully certified medical device soon

    $400-$600

    Price

    12 days

    Duration

    Helpful?
    Yes
    No
  • N
    image-docs

    natabros86

    DK

    Denmark

    5

    Great guy, have deep understanding of Regulatory work related to medical devices. All the best!

    Up to $50

    Price

    6 days

    Duration

    Helpful?
    Yes
    No
  • D
    image-docs

    dlow128

    GB

    United Kingdom

    5

    This was a very useful session, he clearly has a deep understanding of what is required and is professional & polite. Based on our meeting I look to continue working with him. The lack of reviews is not a measure of his abilities. Highly Recommended

    Up to $50

    Price

    2 days

    Duration

    Helpful?
    Yes
    No
Reviews

4 reviews for this Gig
5.0

(4)
(0)
(0)
(0)
(0)
Rating Breakdown
  • Seller communication level
    5
  • Quality of delivery
    5
  • Value of delivery
    5
Sort By
Most relevant
  • A
    image-docs

    ariankamali

    US

    United States

    5

    He is highly professional and has extensive knowledge in regulatory affairs. Thanks to his expertise, my medical device was successfully registered in EUDAMED and has now received CE approval.

    Up to $50

    Price

    4 days

    Duration

    Helpful?
    Yes
    No
  • D
    image-docs

    dlow128

    GB

    United Kingdom

    5

    We are currently working together on a project here. His knowledge of the processes and standards involved are at a very high level. Some more technical documents to come plus the CER. He is always there to answer any questions and is happy to help. We hope to have a fully certified medical device soon

    $400-$600

    Price

    12 days

    Duration

    Helpful?
    Yes
    No
  • N
    image-docs

    natabros86

    DK

    Denmark

    5

    Great guy, have deep understanding of Regulatory work related to medical devices. All the best!

    Up to $50

    Price

    6 days

    Duration

    Helpful?
    Yes
    No
  • D
    image-docs

    dlow128

    GB

    United Kingdom

    5

    This was a very useful session, he clearly has a deep understanding of what is required and is professional & polite. Based on our meeting I look to continue working with him. The lack of reviews is not a measure of his abilities. Highly Recommended

    Up to $50

    Price

    2 days

    Duration

    Helpful?
    Yes
    No

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