Module3 April 20263 min read
Module spotlight: Biocompatibility Testing
If a device touches the body, its materials have to be safe. Biocompatibility testing documents that they are, to ISO 10993.
By MoniDoseQMS Team
Any device that contacts the body — skin, tissue, or bloodstream — must be made of materials that are safe for that contact. Biocompatibility testing documents the biological evaluation that proves it, the foundation of material safety.
What you can do
- Record biocompatibility test protocols and results
- Organise the biological evaluation for your materials
- Link results to materials, design, and risk
- Keep traceable evidence for the technical documentation
Why it matters
The ISO 10993 series governs biological evaluation of medical devices. Capturing it in the QMS keeps material safety evidence connected to the bill of materials and risk file it supports.