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 — including Biological Evaluation Plans (BEP), Biological Evaluation Reports (BER), Toxicological Risk Assessments (TRA), and Clinical Evaluation Reports (CER) — for EU MDR CE Mark and FDA 510(k) 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 MedTechISO 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.