Biological Evaluation
Expert ISO 10993-1:2025 product review and documentation of biological evaluation plans and reports. Biocompatibility made easy.
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Innovation Accelerated
Concierge-level scientific advisory and test subcontracting for medical device manufacturers, built around your milestones.
What we do
Our scientific advisory services give clients the concierge-level support necessary to streamline product registrations. Each offering can be engaged independently or combined into an end-to-end program.
Leachables & Extractables
Streamlined and cost-contained solution for leachables/extractables and toxicological risk evaluation. Tailor-made to meet FDA and EU MDR efficiently.
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Test Subcontracting
Concierge-level sourcing and coordination of biocompatibility testing with the world's leading laboratory service providers. Global reach – local management.
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Additional Services
Concierge-level services for which our team routinely provides expert support to our clients.
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Discovery
We meet with your team to understand the device, the development stage, and the regulatory targets that matter.
Strategy
A tailored plan is built around ISO 10993, FDA, and EU MDR expectations — designed to compress timelines without cutting corners.
Execution
We coordinate evaluations and laboratory partners, manage data quality, and keep stakeholders aligned at every step.
Submission Ready
You receive defensible documentation packaged for regulators and internal review with full traceability.
Capabilities at a glance
Whether you need a single biological evaluation review or an end-to-end testing program, our team plugs in where you need us most.
INSTANT ESTIMATE- ISO 10993-1:2025 biological evaluation planning & reporting
- Chemical characterization and toxicological risk assessment
- Global laboratory sourcing and test plan oversight
- FDA, EU MDR, and international submission support
- Risk management documentation aligned with ISO 14971
- Senior consultants on every engagement — no junior handoffs
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