ISO 10993 compliance, biocompatibility assessment, and toxicological risk evaluation
Our medical device consultation services provide comprehensive support for regulatory compliance, biocompatibility assessment, and toxicological risk evaluation. We help medical device manufacturers navigate complex regulatory requirements and ensure patient safety.
Evaluation and justification writing for high-risk materials including RohS, RSL, SVHC, CMR ED, Nanomaterial, Substance of animal/plant origin, phthalates, PBT etc.
Interpretation and report writing of chemical characterization data from HPLC, MS, FTIR, GCMS, ICPMS, etc.
Biocompatibility endpoint selection, gap assessment, and comprehensive evaluation planning.
Comprehensive toxicological risk evaluation and safety assessment for medical device materials.
Comprehensive BEP (Biological Evaluation Plan) and BER (Biological Evaluation Report) preparation to ensure regulatory compliance and patient safety.
Comprehensive documentation services including Material Safety Data Sheets (MSDS) and Technical Data Sheets (TDS) preparation.
Advanced analytical interpretation and reporting for comprehensive material characterization studies.
Our team has extensive experience with international medical device regulations and standards:
ISO 10993
ISO 18562
FDA Guidance
EU MDR
Get expert guidance on medical device regulatory compliance and safety assessment.
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