MedDev Advisory
MedDev Advisory is an independent medical device biocompatibility consulting practice led by Arvind Rathore, supporting ISO 10993 biological evaluation, BEP, BER, TRA, EU MDR, FDA 510(k), and selected India / CDSCO documentation.
MedDev Advisory identity signals
Independent Practice
MedDev Advisory is a consulting brand, not a regulator, notified body, testing lab, or certification body.
Founder-Led
Project scoping and delivery are led directly by Arvind Rathore for qualified biocompatibility and documentation work.
ISO 10993 Focus
The strongest fit is biological evaluation logic, BEP, BER, TRA, chemistry interpretation, and reviewer-facing remediation.
Global Pathways
Support is framed for EU MDR, FDA 510(k), and selected India / CDSCO documentation where biocompatibility is central.
A specialist biocompatibility practice, not a general regulatory agency
MedDev Advisory exists for medical-device teams that need scientifically grounded ISO 10993 documentation, not generic template writing. The practice is most useful when a file needs clear endpoint logic, defensible waivers, chemistry-to-risk interpretation, or a cleaner response to reviewer questions.
Biological evaluation documents
Biological Evaluation Plans, Biological Evaluation Reports, and toxicological risk assessment logic built around the actual device and contact category.
Regulatory pathway alignment
Support for FDA, EU MDR, and India / CDSCO-facing files where the same evidence base needs to be explained in a reviewer-ready way.
Research-informed judgment
Experience with cytotoxicity, cell response, sterilization effects, biomaterial interaction, and implantable biosensor research informs the documentation approach.
Confidential scoping
Project discussion can begin with an NDA where needed, then move into a scoped proposal based on device type, evidence status, and submission pressure.
Where MedDev Advisory is the strongest fit
The brand should be associated with high-intent biocompatibility problems, not every possible medical-device service.
ISO 10993 Biological Evaluation
Device-specific biological evaluation strategy, contact classification logic, endpoint coverage, and evidence mapping.
BEP and BER Support
Drafting, review, and remediation of Biological Evaluation Plans and Biological Evaluation Reports for submission-facing files.
Toxicological Risk Assessment
TRA logic where chemical characterization results need to be translated into reviewer-facing biological safety conclusions.
FDA 510(k) Biocompatibility
Structured support for biocompatibility sections, Additional Information responses, and FDA-aligned evidence summaries.
EU MDR Biocompatibility
Technical file support where GSPR 10, ISO 10993, risk management, chemistry, and biological evaluation need to connect.
India / CDSCO Readiness
Selected documentation support for Indian manufacturers and export-oriented teams preparing higher-quality biocompatibility files.
Common brand questions
What is MedDev Advisory?
MedDev Advisory is an independent ISO 10993 biocompatibility consulting practice led by Arvind Rathore.
Who founded MedDev Advisory?
MedDev Advisory was founded and is led by Arvind Rathore, a medical device biocompatibility consultant with biomaterials, ISO 10993, and implantable biosensor research experience.
What services does MedDev Advisory provide?
MedDev Advisory supports ISO 10993 biological evaluation strategy, BEP, BER, TRA, EU MDR biocompatibility sections, FDA 510(k) support, and selected India / CDSCO documentation.
Is MedDev Advisory affiliated with ISO, FDA, EU authorities, CDSCO, or notified bodies?
No. MedDev Advisory is an independent consulting practice and is not affiliated with, endorsed by, or approved by ISO, FDA, EU authorities, notified bodies, CDSCO, or the Government of India.
Send the device context and current file state.
MedDev Advisory will help you decide whether the right next step is a BEP, BER, TRA, submission gap review, FDA response, EU MDR remediation, or India / CDSCO documentation support.