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I will write regulatory documents and compliance reports for med devices
About this Gig
Are you looking for a regulatory writing expert to prepare submission-ready documents for your medical device?
With 7+ years of experience in regulatory affairs, ISO 13485 implementation, and international registrations (EU MDR, SFDA, DRAP, FDA), I deliver audit-ready documentation tailored to global compliance standards.
My Expertise Includes:
- Technical File / Design Dossier preparation
- Clinical Evaluation Reports (CER) EU MDR compliant
- Biological Evaluation Reports (BER) ISO 10993 based
- Risk Management Reports (ISO 14971)
- Post-Market Surveillance (PMS) & PMCF Reports
- SOP Development & Quality Documentation
- Regulatory Strategy for EU, KSA, UK, Pakistan, and FDA
Why Choose Me?
Specialized in cardiovascular & Class I/II/III medical devices
Successfully licensed multiple devices with regulatory bodies
High-quality, confidential, and submission-ready documentation
100% client satisfaction tailored to your exact needs
Document type:
Technical Specifications
•
Regulatory Documents
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
Do you also handle regulatory submissions?
I provide submission-ready documents and guide you through the process. However, direct submission to authorities must be done by the manufacturer or authorized representative.
How do you ensure confidentiality?
All documents are handled with strict confidentiality, and NDAs can be signed upon request.
What if I need customized documentation?
I offer custom packages tailored to your project’s scope, just send me a message before placing an order.
