This brief focuses on biocompatibility as a critical component of medical device development and regulatory approval. It explains evolving global expectations, including alignment with ISO 10993 standards and increased scrutiny from regulators. The document highlights common challenges such as incomplete testing strategies, inconsistent documentation, and late-stage remediation. IQVIA’s approach integrates scientific, regulatory, and risk-based methodologies to design efficient biocompatibility programs that support device safety while avoiding unnecessary testing. The brief emphasizes early planning, cross-functional collaboration, and expert interpretation of biological evaluation data to accelerate submissions, reduce rework, and support lifecycle compliance.

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