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Gap Analysis of Biocompatibility Testing per Latest ISO 10993
Customer Background
- SARACA’s customer, a global Medical Device company based in the USA, had Biocompatibility test reports and risk assessment executed back in 2014 for their ENT implants and instruments. The client has selected SARACA to update the test reports and risk assessment per the latest ISO 10993 standard
SARACA’s Expertise
- SARACA utilized its expertise to perform a risk assessment and gap analysis for ISO 10993 testing conducted in 2014 versus the new 2018 version. SARACA updated/developed the following compliance documents:
- Gap analysis in the test protocols and reports per ISO 10993 latest version.
- Gap analysis of ISO 10993 of various tests including genotoxicity, chronic, toxicity, carcinogenicity, etc.
- List gaps in all the reports per ISO 10993 latest version.
- Recommend updates to risk assessment document per latest ISO 10993 requirements.
Challenges
- Various changes in test strategies
- Understanding of applicable testing/applicable standard relevant to the subjected device
Case Studies
We have provided a few projects which we have executd for our customers. Please reach out to us for more details