Medical Device and Pharmaceutical Biocompatibility Testing
End‑to‑end biocompatibility testing and regulatory support – from early development through to market approval and post‑market investigations.
Lucideon brings together decades of materials expertise, advanced analytical capability, and specialist partnerships to deliver comprehensive biocompatibility testing for medical devices and pharmaceutical products. From chemical characterization to cytotoxicity and toxicological risk assessment, we provide a single, trusted partner to help you navigate complex regulatory pathways and accelerate your route to market.
What we do
End‑to‑end biocompatibility testing & regulatory support.
We support medical device manufacturers and pharmaceutical companies at every stage of development – whether you’re preparing a 510(k), responding to regulatory queries, or investigating post‑market issues.
Our solutions are aligned with global regulatory requirements, including FDA, MDR, and PMDA frameworks, ensuring your product meets stringent safety and compliance standards.
Core testing and analysis capabilities
- Chemical characterization (ISO 10993‑18) - assessment of extractables and leachables released under both exaggerated and real‑world conditions to ensure material safety
- Cytotoxicity testing (ISO 10993‑5) - in vitro testing to evaluate the potential of materials and devices to cause harmful effects on living cells
- Toxicological risk assessment (ISO 10993‑17) - delivered in partnership with specialist toxicology experts to provide a complete hazard and risk evaluation programme
- Wear, fatigue & mechanical testing - comprehensive evaluation of device performance using advanced testing rigs and analytical instrumentation
- Particulate analysis - identification and analysis of particle generation, contamination, and shedding throughout the product lifecycle
- Surface analysis - detailed investigation of material surfaces using advanced microscopy and analytical techniques to identify defects, degradation, and changes over time
- Cleaning & sterilization validation - validation of cleaning processes and Instructions for Use (IFUs) to ensure repeatability, effectiveness, and regulatory compliance
From test data to insight: we go beyond testing to provide interpretation, regulatory context, and actionable recommendations – helping you understand risk, optimize development, and progress confidently towards approval.
Why choose Lucideon for biocompatibility testing
- End‑to‑end support:
From early material selection through to regulatory submission and post‑market analysis - Regulatory confidence:
Testing aligned with internationally recognized standards and accepted by FDA, MDR, PMDA, and notified bodies - Partnership approach:
We work alongside your team to understand your product, risks, and regulatory pathway – not just deliver data - Integrated expertise:
Combining materials science, analytical chemistry, biology, and toxicology through in‑house capability and expert partnerships
Who we help
We support organizations developing a wide range of healthcare products, including: orthopaedic implants, surgical instruments, catheters and tubing, dental devices, prosthetics and external devices, and combination products (e.g. injectables, inhalation devices, IV systems).
Typical engagements
- Regulatory pathway support - guidance on testing requirements, programme design, and submission readiness
- Biocompatibility programme design - identification of required ISO 10993 testing and risk‑based strategies tailored to your product
- Failure investigation & troubleshooting - rapid analysis of material interactions and product performance issues
- Process validation - cleaning, sterilization, and manufacturing support to ensure consistent safety and compliance
Expert support at every stage
Not sure which tests are required or how to structure your biocompatibility programme?
Our specialists can sense‑check your approach, identify risks early, and help you avoid unnecessary cost and delay.
Talk to a biocompatibility specialist
Accelerate your route to market with expert guidance and reliable, compliant testing.