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I will products certification of medical devices for ce fda ukca mdr
Your Trusted Partner for Regulatory Compliance and Quality Management
I am a Regulatory Compliance and Quality Management Specialist with over 4 years of experience helping businesses achieve ISO certification, medical device compliance, and regulatory readiness. I spec...
About this Gig
Looking to register your medical devices in the UK, EU, or USA with full regulatory compliance? I'm a Regulatory Affairs Specialist with extensive experience in MHRA, UKCA, FDA, EMA, and MDR compliance. I assist businesses in meeting all regulatory requirements and preparing accurate documentation for medical devices, cosmetics, and healthcare products.
Services I provide:
- MHRA registration for medical devices and UKCA certificates
- FDA device registration, device listing, and US FDA agent services
- ISO 13485 technical documentation for medical devices
- FDA 510(k) support, regulatory compliance reviews, and guidance
- MDR compliance and EC Certificate of Conformity for EU market access
I ensure that your documentation is clear, compliant, and professionally prepared to meet the latest regulatory standards in the UK, EU, and USA. Whether you need FDA registration, device listing, or UKCA compliance, I provide end to end solutions to help you navigate the regulatory landscape with ease.
Get expert support for FDA compliance, MDR, and smooth market entry for your medical devices!
MESSAGE OR ORDER ME NOW!! for a free consultation or place your order today and secure your FDA approval !!
Type of Business:
LLC
•
LTD
Service type:
State business registration
Target country:
Worldwide
•
United Kingdom
•
United States
Business formation & registration Gigs are not screened
Fiverr does not pre-screen freelancers offering services in Business Formation & Registration. We advise thoroughly reviewing freelancer profiles, asking questions, and confirming their qualifications to ensure they meet your requirements. Freelancers marked as “Pro” have completed a vetting process for added confidence. Learn more here.
FAQ
What is the process for FDA device registration and how can you help me?
The FDA device registration process is essential for businesses looking to market medical devices in the United States. I provide FDA registration services, including FDA device listing, US FDA agent services comprehensive FDA compliance support. Whether you're registering Class I, II, or III device
How do I register my medical device in the UK and EU?
To register your medical device in the UK, you need MHRA registration and UKCA certificatesIn the EU, youll need to comply with the MDR regulations and obtain an EC Certificate of Conformity. I offer regulatory compliance services for both UKCA and MDR compliance to help you navigate the registrati
What is ISO 13485 technical documentation and why is it important for my device?
SO 13485 technical documentation is crucial for demonstrating your device’s compliance with international standards. I help prepare ISO 13485 documentation, including device classification, risk assessments, and clinical evaluations, ensuring your device meets the necessary regulatory compliance
How do I know if my medical device needs a 510(k) for FDA approval?
A 510(k) submission is required for many devices to enter the U.S. market. I offer FDA 510(k) support to help you prepare the necessary documentation and ensure your device meets FDA regulatory compliance.
Do you provide FDA device listing and annual renewals?
Yes! I handle FDA device listing and annual renewals, ensuring your device remains compliant with FDA regulations and avoiding penalties.
