Biocompatibility - Toxicity Testing Procedure | ISO 13485 | FDA QSR Compliant
- ISO 10993-1, 2018 Compliant
- ISO 14971, 2019 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR 2017/745 Compliant
- MS Word Format
- Digital Content - Instant Download
Biocompatibility ProcedureThe Biocompatibility Procedure governs the biological evaluation of materials and medical devices. The Biocompatibility Procedure is aligned with ISO 10993-1, 2018, ISO 14971:2019, MDR 2017/745 and FDA QSR.
Biocompatibility Procedure OverviewThe Biocompatibility Procedure applies to the biological evaluation of materials and medical devices for use in humans.
The Biocompatibility Procedure includes a sample protocol and final report that provides guidance on overall structure and required content. Biocompatibility Procedure ComplianceThe Biocompatibility Procedure is ISO 10993-1, (2018), ISO 14971:2019, MDR 2017/745, FDA 21 CFR Part 820, and ISO 13485:2016 compliant.
To learn more about our Biocompatibility Procedure contact us at [email protected]
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