Independent Expert Consulting · Medical Device & Pharmaceutical Safety Science

Me Medical Expert

Independent medical expert consulting delivering ISO 10993-17 compliant toxicological risk assessments, TRA/TIR documentation, and margin-of-safety calculations for FDA 510(k), PMA, CE Mark, and MDR regulatory submissions.

ISO 10993-17 TRA / TIR MoS Calculation NOAEL / LOAEL Risk Characterisation
Harish Hazard & Risk Integrated Safety & Health

End-to-end gap analysis and regulatory strategy — identifying missing safety data, benchmarking against ISO 10993, FDA, and EMA expectations, and delivering a prioritised remediation roadmap to close compliance gaps efficiently.

Gap Analysis Hazard Identification Risk Remediation ISO 10993-1 Alignment Regulatory Strategy
Bio Biological Science

Comprehensive biological and chemical evaluation — BEP & BER authoring, E&L assessment, chemical characterisation (ISO 10993-18), and cytotoxicity, sensitisation, and genotoxicity endpoint justification under ISO 10993-1.

BEP / BER Biocompatibility Cytotoxicity E&L / ISO 10993-18 Genotoxicity
Sim Safety In Medicine

Strategic safety consulting — identifying regulatory and testing gaps in biocompatibility packages and toxicological dossiers, benchmarking against ISO/FDA/EMA expectations, and building a prioritised gap-remediation roadmap.

Gap Analysis Regulatory Gap ISO 10993-1 TTC / QSAR Remediation Plan
Explore Services
Emailinfo@meharishbiosim.com
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Phone+1 (612) 488-9796

Our Services

Consulting · Strategy Planning · Subject Matter Expertise

Toxicology Risk Evaluation
ISO 10993-17 Compliant TRA

Systematic assessment of chemical hazards and patient exposure risks associated with medical devices, aligned with ISO 10993-17. Delivers scientifically defensible Toxicological Risk Assessments (TRA) and Tolerable Intake (TI) calculations to support FDA 510(k), PMA, CE Mark, and MDR regulatory submissions.

ISO 10993-17 TRA / TIR MoS Calculation NOAEL / LOAEL Risk Characterisation Tolerable Intake
Biocompatibility Assessment
ISO 10993-1 Biological Evaluation

Comprehensive biological evaluation of medical devices to determine safety for intended human contact, in accordance with ISO 10993-1. Includes development of Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER) tailored to device classification and contact duration.

BEP / BER ISO 10993-1 Cytotoxicity Sensitisation Genotoxicity Device Classification
Gap Analysis & Chemical Evaluation
ISO 10993-18 · Regulatory Remediation

Identification of missing biological safety data, regulatory deficiencies, and non-conformances against current ISO 10993 standards — with a clear remediation roadmap. Paired with rigorous extractables and leachables (E&L) characterisation under ISO 10993-18 to ensure complete chemical safety documentation.

Gap Analysis E&L / ISO 10993-18 QSAR / TTC Remediation Plan Chemical Characterisation Regulatory Compliance