Arvind Rathore
ISO 10993 Biocompatibility Consultant · MTech IIT Kanpur · Marie Curie Fellow INSERM · Founder MedDev Advisory
Arvind Rathore
ISO 10993 Biocompatibility Consultant
BEP · BER · TRA | Cytotoxicity & Cell-Response Research
ISO 10993 Expert with a Research Foundation in Biocompatibility Science
I help medical device companies prepare ISO 10993 biological evaluation documentation — especially Biological Evaluation Plans (BEP), Biological Evaluation Reports (BER), Toxicological Risk Assessments (TRA), and reviewer-facing biocompatibility sections for EU MDR and FDA submissions.
My approach is grounded in direct bench-level research experience in biomaterials science and biocompatibility evaluation. Through a Marie Skłodowska-Curie Fellowship at INSERM U1026 Biotis in Bordeaux, France, I conducted hands-on research on implantable electrochemical biosensors — studying cytotoxicity mechanisms, oxidative stress responses to biomaterials, and cell-material interactions relevant to ISO 10993 evaluation endpoints.
I founded MedDev Advisory to bridge the gap between regulatory compliance requirements and the underlying biological science. When I prepare a BER, I understand each endpoint at a mechanistic level — not just as a checkbox on a regulatory form. This scientific depth translates into documentation that is more defensible under notified body and FDA scrutiny.
I work with MedTech startups, established manufacturers, contract manufacturers, and R&D teams preparing CE Mark or FDA 510(k) submissions across a range of device categories, with particular depth in implantable devices and long-term contact categories.
Real biocompatibility science — not template writing. When I write your BER, I understand the science behind each endpoint, not just the regulatory requirement.
Best Fit Engagements
- Submission teams with a defined device, pathway, and documentation gap
- FDA AI or notified body remediation that needs fast technical writing support
- Legacy BEP or BER files that need stronger ISO 10993-1:2025 framing
How I Usually Work
- Short scoping review first, then a fixed-scope proposal for the deliverable
- Direct collaboration with founders, RA/QA leads, or submission consultants
- Confidentiality-first workflow, with NDA available before device-specific review
Founder-led delivery, with vetted specialists where a project genuinely needs more depth.
For selected scopes beyond the core ISO 10993 documentation work, I may collaborate with experienced specialists under a defined project model. That now includes carefully bounded India / CDSCO projects where the scope requires real local regulatory depth rather than broad unsupported claims.
For a clearer sense of delivery style and broader submission context, review the representative case studies and the medical device regulatory framework guide.
Core Areas of Expertise
ISO 10993 Biological Evaluation
Expert-level knowledge across ISO 10993-1 (2018 & 2025), 10993-5 (Cytotoxicity), 10993-10 (Sensitization & Irritation), 10993-17 (TRA), and 10993-18 (Chemical Characterization).
Cytotoxicity & Cell-Response Research
Hands-on cytotoxicity assay experience (ISO 10993-5 endpoints), oxidative stress response studies, and cell-material interaction analysis from INSERM research on implantable biosensors.
EU MDR Biocompatibility Documentation
EU MDR 2017/745 Technical Documentation with emphasis on Annex I GSPR biocompatibility requirements, Annex II integration, notified body responses, and the parts of CER or PMCF work that directly intersect with biological evaluation.
FDA 510(k) Biocompatibility
FDA-aligned biocompatibility documentation per the FDA guidance on use of ISO 10993-1 (2020, updated 2023). Experience with 510(k) sections, De Novo submissions, and PMA biocompatibility summaries.
Biomaterials & Implantable Devices
Research expertise in implantable electrochemical biosensors — one of the most demanding biocompatibility categories requiring genotoxicity and carcinogenicity pathway evaluation.
Supporting Scientific Writing
Published researcher in Bioelectrochemistry (Elsevier, 2025) and Advanced Sensor Research (Wiley, 2024). I use that writing background to strengthen literature-backed regulatory sections and adjacent scientific communication when it supports the core biocompatibility scope.
Career & Education Timeline
ISO 10993 Biocompatibility Consultant
MedDev Advisory (Independent Founder)
Independent ISO 10993 biocompatibility consulting practice supporting medical device companies with biological evaluation documentation for EU MDR, CE Mark, and FDA 510(k) submissions. Providing scientifically defensible BEP, BER, TRA, and regulatory documentation.
Independent Medical Device Documentation Consultant
Independent
Worked independently on biomaterials, biosensors, scientific writing, and medical device documentation. This phase deepened focus on biocompatibility evaluation, literature-based assessment, and regulatory documentation — forming the foundation for the MedDev Advisory consulting practice.
Early Stage Researcher (ESR)
INSERM U1026 Biotis · Bordeaux, France
Marie Skłodowska-Curie Early Stage Researcher at INSERM under the EU Horizon 2020 program. Research focused on the biological evaluation of implantable electrochemical biosensors — including cytotoxicity assays (ISO 10993-5 endpoints), oxidative stress response, biomaterial-cell interactions, and sterilization effects on device biosafety.
Collaborated with CNRS, Ruhr University Bochum (Germany), and AptuSens AB (Sweden) within international biomedical research teams.
Master of Technology (MTech)
Indian Institute of Technology Kanpur (IIT Kanpur)
MTech in Biological Sciences and Bioengineering from IIT Kanpur — one of India's top 5 engineering institutions. Provided the academic foundation in bioengineering, biomaterials science, and biological systems that underpins all consulting work.
Research Collaborations & Publications
INSERM U1026 Biotis
Bordeaux, France
Primary research institute for Marie Skłodowska-Curie fellowship. Conducted biological evaluation research on implantable biosensors under the EU Horizon 2020 program.
CNRS
France
Collaborative research in biomaterials and biosensor development. Joint scientific work within the Horizon 2020 research network.
Ruhr University Bochum
Bochum, Germany
International collaboration on electrochemical biosensor research, electrode fabrication, and biomedical device development within the EU Horizon 2020 framework.
AptuSens AB
Sweden
Industrial collaboration in biosensor development and commercialization strategy. Contributed to device-level biocompatibility and biosafety evaluation within the project consortium.
Peer-Reviewed Publications
Bioelectrochemistry · 2025
Research on implantable glucose biosensors, sterilization effects, and biomaterial-host biological interactions relevant to ISO 10993 evaluation endpoints.
Advanced Sensor Research · 2024
Research on advanced biosensor development, electrochemical testing methodologies, and device-related biological safety evaluation for implantable applications.
Awards, Fellowships & Certifications
Marie Skłodowska-Curie Fellowship
EU Horizon 2020
Prestigious European research fellowship awarded for research on implantable biosensors, biocompatibility, and biological safety evaluation. Strengthened expertise in biomaterials, cell-material interactions, and ISO 10993 assessment.GATE (Graduate Aptitude Test in Engineering)
Government of India
National-level engineering entrance examination qualifying for IIT Kanpur MTech admission. GATE is one of India's most competitive engineering examinations.AICTE Fellowship
All India Council for Technical Education
Fellowship awarded by AICTE in recognition of academic merit and research potential in engineering and technology disciplines.Post Graduate Exam Fellowship
Academic Excellence
Post-graduate examination fellowship recognizing academic performance and research contribution during MTech studies at IIT Kanpur.Intellectual Property Rights (IPR)
Patent Application Training
Certification in intellectual property rights and patent application process — relevant to protecting innovations in medical device development and biomaterial research.Regulatory Training in Animal Experimentation
Biomedical Research Compliance
Regulatory training in rodent surgery and animal experimentation ethics — foundational to in vivo biocompatibility evaluation methodology and ISO 10993 in vivo endpoint understanding.Technical Skills & Competencies
Regulatory Standards
Research & Science
Documentation
Research Methodology
Work with an ISO 10993 Expert
Who Knows the Science
Request a short scoping call to discuss your device, the current documentation gap, and the most practical next step.