Discuss Your ISO 10993
or Regulatory Project
Share your device, regulatory pathway and deadline. Project enquiries receive a scoped response when the work is a fit; handbook and toolkit purchase requests use the dedicated written-offer form.
Send an Inquiry
Use this form for documentation, pre-submission review, deficiency-response support, India / CDSCO work, or interest in a MedDev Advisory publication. For project work, precise device and regulatory details help me scope the right next step.
Best Fit For This Form
- New BEP, BER, or TRA drafting
- FDA or notified body deficiency response
- Legacy BER updates for ISO 10993-1:2025
- CDSCO / India planning or documentation-readiness support
- Interest in a book under release review or development
For The Fastest Scope Review
- Device type, contact duration, and materials
- Target pathway: EU MDR, FDA 510(k), PMA, India / CDSCO, or multi-market
- Any current gap, reviewer query, or submission deadline
Your next step will appear here.
Best for teams that already have a device, a pathway, and a concrete deliverable or reviewer issue to resolve.
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.
Initial Scoping Call
We review your device, regulatory target, existing documentation, and timeline so I can confirm fit and define scope.
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, FDA 510(k), or India / CDSCO where relevant).
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.
Yes. That is one of the best ways to start if your team already has draft documentation. I can review an existing BEP, BER, TRA, or biocompatibility section, identify the highest-risk gaps, and tell you whether the file needs light adaptation, deeper remediation, or a full rewrite.
Each deliverable (BEP, BER, TRA) includes preparation of the document to the agreed scope, delivery in Word and PDF format, and one round of revisions. If the need is a review, remediation, or India / CDSCO project, the exact scope is defined first so the quote matches the real work.
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.
They start with device type, intended use, pathway, documentation status, target market, and the specific decision you need to make. From there, I define whether the best next step is pathway review, documentation-readiness review, ISO 10993 evidence planning, or a separate formal filing support need.
Yes. For qualified projects, I can work under NDA before reviewing device-specific materials. If your organization has supplier onboarding or confidentiality requirements, mention that in the inquiry and I will factor it into the next step.
I review the device type, pathway, current documentation status, and deadline, then reply with the likely scope, what I would need next, and whether a short scoping call makes sense. The goal is to qualify the work quickly, not force an unnecessary meeting.