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I will help with eu mdr compliance and eudamed registration mhra registration
Hazel Damian
About this gig
Looking to register your medical device and meet EU MDR or MHRA regulatory requirements? I provide professional regulatory affairs support to help manufacturers, startups, importers, and healthcare companies achieve compliance efficiently.
My Services Include:
EU MDR Registration Support
MHRA Registration Support
EUDAMED Actor Registration & SRN Guidance
EU MDR Documentation Review
Technical File Documentation
Medical Device Classification
Declaration of Conformity (DoC)
ISO 13485 Documentation Support
Risk Assessment & Gap Analysis
Label & IFU Compliance Review
Regulatory Affairs Consultation
Why Choose Me?
Accurate, confidential, and professional service
Fast communication and on-time delivery
Tailored solutions for startups and manufacturers
Support aligned with current EU MDR and UK MHRA requirements
Whether you're launching a new medical device or updating existing documentation, I'll help simplify your compliance process with reliable regulatory support.
Please contact me before placing your order so I can review your requirements and recommend the best package.
Get to know Hazel Damian
Hazel Damian
EU MDR And Medical Device Regulatory Affairs Specialist
- FromGermany
- Member sinceJul 2026
- Avg. response time1 hour
Languages
English, German, French, Italian
I help medical device manufacturers, startups, and healthcare businesses achieve regulatory compliance with confidence. I specialize in EU MDR documentation, EUDAMED, MHRA registration support, Technical File preparation, ISO 13485 documentation, device classification, risk assessment, and regulatory compliance. My focus is delivering accurate, confidential, and high-quality work with clear communication and on-time delivery.
FAQ
What information do you need to get started?
Please send your product details, device classification (if available), intended market (EU or UK), existing documentation, and any regulatory requirements. If you're unsure, simply share your product information, and I'll review your project before we begin.
Can you support both EU MDR and MHRA registration?
Yes. I provide professional support for EU MDR documentation, EUDAMED registration, and MHRA registration for eligible medical devices, ensuring your documentation is prepared accurately and in line with current regulatory requirements.
What types of medical devices do you work with?
I support a wide range of medical devices, including Class I, Class IIa, Class IIb, and Class III devices. Please contact me before ordering so I can confirm your project requirements.
Do you prepare Technical File and regulatory documentation?
Yes. I prepare and review essential regulatory documentation, including Technical File documentation, Declaration of Conformity (DoC), device classification, risk assessment, and other EU MDR compliance documents based on your package.
Is my project and business information kept confidential?
Absolutely. Every project is handled with strict confidentiality, and your documents and business information are never shared with third parties.
Should I contact you before placing an order?
Yes. Please message me before ordering so I can review your project, confirm your requirements, and recommend the package that best fits your medical device and regulatory needs.
