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I will classify your medical device for eu mdr and fda regulations
Sara H
About this gig
Are you developing a medical device and need help determining its regulatory classification?
I provide professional support for medical device classification under EU MDR and FDA regulations. Correct classification is essential to identify the appropriate regulatory pathway and ensure compliance.
I hold an Engineering degree in Biomedical Engineering from City, University of London, UK, giving me a strong technical understanding of medical devices and regulatory requirements.
Services I offer:
Medical device classification according to EU MDR
FDA medical device classification guidance
Identification of regulatory pathway
Classification justification and explanation
Guidance on next regulatory steps
Why choose my service?
Biomedical engineering background in medical devices
Clear regulatory guidance
Fast and reliable communication
Confidential handling of your project
Please get in touch with me before placing an order so I can review your device description and intended use.
Get to know Sara H
Sara H
Biomedical Engineer, Medical Device Regulatory Consultant, EU MDR and FDA
- FromPakistan
- Member sinceAug 2025
Languages
English, Urdu
Biomedical Engineer (BEng, City University of London) providing regulatory guidance for medical devices targeting EU and US markets. I support startups and manufacturers with EU MDR and FDA device classification, regulatory pathway guidance, CE Technical File documentation structure, ISO 14971 risk management framework, and labeling/IFU compliance review. My goal is to simplify regulatory requirements and help clients understand the steps needed for CE marking and FDA clearance.
Please contact me before ordering so we can discuss your device and regulatory needs.
FAQ
What information do you need?
A short description of the device, its intended use, and the target market (EU or US)
Do you guarantee regulatory approval?
No. This service provides regulatory guidance only and does not guarantee CE marking or FDA clearance.
What format will the report be delivered in?
You will receive a structured PDF report summarizing classification and regulatory considerations.
Can you review my existing documentation?
Yes, document review can be included in custom orders.
Will my medical device information remain confidential?
Yes. All information you share about your medical device, including device descriptions, documentation, and technical details, will be handled with strict confidentiality. Your project information will never be shared with third parties.
