Ensuring Safety for Patient Contact and Implantation
Biocompatibility testing determines whether a medical device and its materials are suitable for safe human contact. As mandated by FDA and EU MDR, every device must undergo biological evaluation according to the ISO 10993 series.
BQCIS conducts complete ISO 10993-1 evaluations—beginning with risk assessment and test-plan design, through in vitro and in vivo studies—to verify biocompatibility for Class I–III devices.
Our protocols ensure that devices—from single-use tools to long-term implants—do not cause toxicity, irritation, or sensitization. We deliver fully documented data packages that accelerate regulatory submissions and safeguard patient safety.
Key Biocompatibility & Evaluation Services
Key Benefits of Biocompatibility Testing
Assure Patient Safety
Confirms materials are non-toxic and non-sensitizing, protecting patients from local or systemic reactions.
Meet Global Regulatory Expectations
Fully aligned with FDA, EMA, and MDR requirements under ISO 10993, ensuring smooth market access.
Reduce Time & Cost to Approval
Chemical characterization and risk-based approaches can replace lengthy in vivo studies, accelerating submission.
Build Regulatory Confidence
Comprehensive biological data and defensible documentation demonstrate device safety and reliability.
Success Story
E&L Data Eliminates Need for In Vivo Testing
A manufacturer of a long-term implantable device faced costly animal testing to satisfy FDA biocompatibility requirements.
BQCIS applied ISO 10993-18 & -17 methodologies using high-resolution mass-spectrometry to characterize all extractables and establish safe exposure limits, replacing the need for in vivo studies.
The regulator accepted the toxicological risk assessment in lieu of animal data, saving ≈ $500 k and 8 months, while achieving full compliance and market clearance.