I will do tech documentation mdr sfda fda ukca tga and amazon devices
Regulatory Specialist, Technical Writer, CER Expert, Data Analyst
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
FAQ
What type of medical devices do you specialize in documenting?
Our comprehensive services include creating and maintaining documentation for medical devices, ensuring regulatory compliance with various international guidelines, and providing support for Amazon listings. We focus on delivering high-quality work tailored to our clients' specific needs and require
Are your writers knowledgeable in regulations?
Our experienced writers are well-versed in numerous regulations, including MDR (EU Medical Device Regulation), FDA (US Food and Drug Administration), UKCA (UK Conformity Assessed), and TGA (Australia's Therapeutic Goods Administration). This ensures accurate and compliant documentation.
How long does a project take?
The duration of each project is determined by its complexity and scope. We work closely with our clients to establish realistic timelines, allowing us to deliver results efficiently without sacrificing quality. Communication is key, and we continually update clients on progress.
What is your pricing structure?
Our pricing model is custom and based on the specific requirements of each project. We assess factors such as complexity, scope, and deadlines to determine a fair and competitive price. Our goal is to deliver exceptional value while accommodating clients' budgets.
How do you ensure confidentiality and IP protection?
We take confidentiality and intellectual property protection very seriously. We adhere to strict non-disclosure agreements and employ security measures to safeguard clients' sensitive information. We respect the trust placed in us and work diligently to maintain client privacy.
4 reviews for this Gig
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Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
A ariankamali

United States
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?D 
dlow128

United Kingdom
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
H Seller's Response
Helpful?N 
natabros86

Denmark
Great guy, have deep understanding of Regulatory work related to medical devices. All the best!
Up to $50
Price
6 days
Duration
H Seller's Response
Helpful?D 
dlow128

United Kingdom
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?
4 reviews for this Gig
| (4) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
A ariankamali

United States
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?D 
dlow128

United Kingdom
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
H Seller's Response
Helpful?N 
natabros86

Denmark
Great guy, have deep understanding of Regulatory work related to medical devices. All the best!
Up to $50
Price
6 days
Duration
H Seller's Response
Helpful?D 
dlow128

United Kingdom
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?

