Send a Project Inquiry
Fill in the form below with your project details. The more information you provide, the better I can prepare for our conversation.
Arvind Rathore
ISO 10993 Biocompatibility Consultant
Kanpur, IndiaI respond within 24 hours on business days.
What to Expect
Receive Your Inquiry
I review your project details and prepare relevant questions for our call.
Free 15-Min Call
We discuss your device, regulatory target, existing documentation, and timeline — no obligation.
Scope & Proposal
I define the documentation scope, deliverables, and provide a clear timeline and fixed price.
Begin Documentation
Once agreed, I begin preparation of scientifically defensible, submission-ready documentation.
Frequently Asked Questions
For a BEP, I need: device name and description, intended use and patient population, materials/components (including supplier information if available), device contact classification (or information to determine it), sterilization method, and the regulatory target (EU MDR or FDA 510k).
A BEP is typically delivered in 3–5 business days from receipt of complete device information. A BER requires 5–7 business days. Timeline starts once all necessary device information is received. Complex devices may require additional time.
Each deliverable (BEP, BER, TRA) includes: preparation of the document per ISO 10993-1:2025 requirements, delivery in Word and PDF format, and one round of revisions. Revisions are incorporated based on your feedback after document delivery.
Yes. Notified body biocompatibility queries are one of my most common projects. I review the query, identify the gaps in the existing documentation, and prepare a structured scientific response that addresses each point raised by the notified body.
I work via both Upwork (for clients who prefer the platform's project management and payment security) and directly for established relationships. For Upwork engagements, my rate is $55/hr. Please indicate your preference in the project inquiry.
Yes, completely free. The 15-minute call is an introductory conversation for me to understand your project and for you to assess whether I am the right consultant. No commitment required. I respond to all inquiries within 24 hours on business days.