Any device that touches the body, the skin, the bloodstream or internal tissue, must prove it does no harm. The ISO 10993 series tells you which tests are required, how to plan them, and how to interpret the results. We help you build a biological evaluation that is right-sized to your device.
ISO 10993 is a series of standards covering the biological evaluation of medical devices. The flagship is ISO 10993-1, which sets out the framework. Individual parts cover specific tests: cytotoxicity, sensitisation, irritation, systemic toxicity, genotoxicity, and more.
The modern approach is chemistry-led: characterise the materials and extractables first, then test only where chemistry does not already answer the safety question. This saves time, animals and money, while building a stronger safety argument.
From device categorisation to a defensible biological evaluation report, we help you avoid the two common traps: testing too much, or testing too little.
A clear biological evaluation plan based on actual body contact, duration and materials. The foundation that saves you money downstream.
We design a strategy that leans on ISO 10993-18 characterisation and toxicological risk assessment to reduce or replace animal testing wherever defensible.
Selecting the right lab, designing the protocol, and managing the timeline. We have worked with labs across Europe, the U.S. and APAC.
Expert toxicologist-led TRA following ISO 10993-17 to bridge chemistry data to clinical safety conclusions.
We author or review your BER so it ties the plan, the data and the conclusion into a story your auditor can follow.
If your supplier changes a material or process, we assess whether new testing is needed, or whether existing data plus a justification is enough.
FDA has its own guidance (G95-1, the 2023 update of FDA biocompatibility guidance) which sometimes asks for more rigour than ISO 10993-1 alone, particularly on chemistry and toxicology. We map evidence to both. Any material or process change in the supply chain can affect biocompatibility. The first step is a documented change assessment. Often a justification plus targeted retesting is enough. Sometimes you need a full re-evaluation. From planning to a complete biological evaluation report, expect 3 to 9 months depending on tests required, lab availability and complexity. Chemistry-led strategies are often faster than legacy testing-only approaches.
No. The modern approach is to characterise the device chemically (ISO 10993-18) and run a toxicological risk assessment first. Testing is then targeted to the gaps that chemistry cannot answer.
Modern methods (in vitro, in chemico, in silico) are increasingly accepted, especially for sensitisation and irritation. Combined with chemistry, they can replace some animal tests. We design strategies that take advantage of this trend.