Trust, Credentials & Confidentiality for International Buyers
MedDev Advisory is an India-based ISO 10993 practice founded by Arvind Rathore, a former Marie Skłodowska-Curie Early Stage Researcher at INSERM. This page is for buyers who want to verify the person, the working process, the confidentiality boundary, and the limits of what is being promised before sharing sensitive device information.
Visible Human Identity
The site shows the named founder, photo, location, professional background, direct email, founder's LinkedIn profile, and clear contact path.
Scientific Foundation
Biocompatibility work is positioned around ISO 10993 reasoning, cytotoxicity/cell-response research, biomaterials, and reviewer-facing documentation.
Confidentiality First
Device-specific files, material details, reviewer letters, and test reports can be handled after an NDA or agreed confidentiality boundary.
No False Guarantees
The site does not claim regulatory approval, notified body acceptance, FDA clearance, laboratory acceptance, or authority endorsement.
The goal is to make trust checkable, not just claimed
International medical-device teams are right to be cautious before sending draft BEPs, BERs, chemistry reports, toxicological risk assessments, material details, or reviewer questions to a consultant they have not worked with before.
MedDev Advisory is therefore built around a simple trust model: visible founder identity, precise credential language, confidentiality-first onboarding, written scope before paid work, conservative regulatory claims, and clear boundaries around what consulting can and cannot do.
Credentials are stated precisely, with verification paths
This section separates the claim, the relevance to your project, and the practical way a serious buyer can verify or discuss it during due diligence.
Founder Identity
Arvind Rathore is the named founder and direct consultant behind MedDev Advisory. The site uses a real profile photo, direct email, and a named practice rather than anonymous service delivery.
Marie Skłodowska-Curie / INSERM Research
Arvind was a Marie Skłodowska-Curie Early Stage Researcher at INSERM U1026 Biotis in Bordeaux within the ImplantSens network. His work involved implantable electrochemical biosensors, cytotoxicity, cellular responses, biomaterial–cell interactions, sterilization effects, and foreign body response questions.
International Research Placements
The ImplantSens programme included visiting research in France, Germany and Sweden: CNRS in Pessac, Ruhr University Bochum, and Malmö University / AptuSens AB. The work covered porous-electrode fabrication, enzyme immobilization, miniaturized glucose-sensor electrodes and electrochemical characterization.
Published Researcher
Published research experience is used to support literature-backed regulatory writing and stronger scientific explanation, especially where biological evaluation requires clear endpoint reasoning rather than generic template text.
IIT Kanpur Background
MTech in Biological Sciences and Bioengineering from the Indian Institute of Technology Kanpur, with thesis research on silk-based biomaterials for tissue-engineering applications.
ISO 10993 Focus
The consulting scope is centered on ISO 10993 biological evaluation, BEP, BER, TRA, EU MDR biocompatibility sections, FDA 510(k) biocompatibility support, and reviewer-response work.
How sensitive device information is handled
The safest projects start with enough context to scope the work, then move into detailed document review only after the confidentiality boundary is clear.
Initial non-confidential inquiry
Share device category, contact type, target market, deadline, and the general problem without exposing proprietary material formulas or full reports.
Fit and scope screen
The project is checked for fit, likely deliverable, timeline, conflict concerns, and whether an NDA is appropriate before deeper file review.
NDA or written boundary
For qualified projects, an NDA can be signed before reviewing device-specific materials, draft files, reviewer letters, test reports, or chemistry data.
Controlled delivery
Work begins only after scope, deliverables, timeline, fee, revision expectations, and client responsibilities are agreed in writing.
Why India-based does not mean India-only
MedDev Advisory is based in Kanpur, India, but the service positioning is global: ISO 10993 biological evaluation, EU MDR technical documentation, FDA 510(k) biocompatibility sections, and export-oriented medical-device documentation.
- Written communication and deliverables are in English.
- Work can be scoped around EU, US, UK, APAC, India, or multi-market documentation needs.
- Scheduling can accommodate EU, US, and APAC overlap where project urgency requires it.
- India-specific CDSCO support is treated as one market vertical, not the whole brand identity.
How the work is kept commercially safe
Trust is not only about credentials. It is also about reducing buyer risk before a project starts.
- No full confidential file review is required before the confidentiality boundary is clear.
- Scope, deliverables, and expected inputs are written before paid consulting work begins.
- Representative examples are anonymized so client confidentiality is not traded for marketing proof.
- Legal, regulatory-authority, notified-body, and laboratory roles are not misrepresented.
Important professional boundaries
Strong trust also means saying clearly what this website and service do not promise. MedDev Advisory provides consulting and documentation support based on client-supplied information. Final regulatory decisions remain with the manufacturer and its responsible regulatory, quality, clinical, toxicology, laboratory, and legal teams.
Where to look next if you are evaluating fit
Founder Background
Review the detailed professional background, research experience, publications summary, and collaboration history on the About page.
Case Patterns
Review anonymized examples showing what types of BEP, BER, TRA, FDA response, and legacy-file problems the work is designed to solve.
Deliverable Structure
Review redacted document-structure examples that show the kind of logic used without exposing confidential client information.
Questions overseas buyers often ask before contacting
Can we speak before sharing confidential files?
Yes. A first inquiry can stay high-level: device category, contact type, target market, deadline, and current problem. Detailed files can wait until the confidentiality boundary is clear.
Can you sign our company NDA?
For qualified projects, yes. If your organization has its own NDA or supplier onboarding process, mention it in the inquiry so it can be reviewed before device-specific information is exchanged.
Can you work with our internal RA/QA or consultant team?
Yes. Many projects fit best when MedDev Advisory supports the biological evaluation or reviewer-response portion while the client's internal team controls submission ownership.
Can you provide a fixed-scope proposal?
Yes. The normal path is inquiry, fit review, scoped deliverable, fixed timeline, written assumptions, and agreed revision expectations before work begins.
Want to check fit without over-sharing?
Send a short non-confidential summary of the device type, patient-contact category, target pathway, and the current file problem. I will respond with the safest next step and whether an NDA should come before document review.