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$
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I will develop iso 13485, fda, mhra, UK mdr technical documentation and registration
Level 1
Has met certain performance criteria and shows strong potential in the marketplace.
Highly Responsive
Known for exceptionally quick replies
About this Gig
Do you need expert support with medical device compliance, FDA registration, MHRA documentation, or ISO 13485 system development? You're in the right place!
I provide complete regulatory affairs consulting to ensure your products meet FDA, EMA, MHRA, UK MDR, and UKCA requirements. From startups to established manufacturers, I help you prepare accurate, audit-ready, and compliant documentation tailored to your market.
My Services Include:
- ISO 13485 QMS documentation & SOPs
- Technical Files & Declarations of Conformity
- MHRA registration & UK Responsible Person support
- UK MDR & UKCA compliance documentation
- FDA registration, listing & eCTD Modules 15
Why choose me? I bring deep regulatory knowledge, precise documentation, and strategic guidance to avoid costly delays or rejections. With a proven track record in regulatory compliance & technical submissions, Ill help you achieve approval faster and keep your products aligned with international standards.
Lets ensure your product is regulatory-ready and positioned for successful approval in global markets.
Document type:
Documentation
•
Reports
Industry:
Medical & biotech
Language:
English
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.
FAQ
Can you assist with both FDA and MHRA registrations?
Yes. I provide compliance support for FDA, EMA, MHRA, UK MDR, and UKCA requirements, including technical documentation and eCTD submissions.
Do you act as a UK Responsible Person (UKRP)?
Yes, I can assist with UKRP representation or guide you in appointing one for MHRA compliance.
What documents are included in the ISO 13485 package?
Quality Manual, SOPs, Risk Management, Technical Files, and other required compliance documents.
Can you prepare eCTD submissions for FDA, EMA, and MHRA?
Absolutely. I prepare Modules 1–5 in line with current requirements to ensure submission-ready files.
Do you guarantee approval from regulatory authorities?
While approval depends on the product’s compliance and data provided, I guarantee accurate, compliant documentation that meets regulatory standards.
