Medical Devices – Biological Safety
Comprehensive Biocompatibility Assessment for ISO 10993 Compliance
Ensuring the biological safety of medical devices is a critical aspect of regulatory compliance and market approval. At CRONET, we provide specialized consulting services to help companies meet the stringent requirements of the ISO 10993 series, ensuring the safety and effectiveness of their products throughout their lifecycle.
Our team of experts assists in developing strategic, risk-based approaches to biocompatibility, minimizing delays and optimizing testing plans to align with international regulatory expectations. Whether you are in the early design phase or preparing for submission, we offer end-to-end support to ensure compliance with global safety standards.
Biological Risk Assessment
A thorough identification and evaluation of biological risks following ISO 10993-1 guidelines. Our team conducts data gap analysis, risk characterization, and documentation to ensure a clear safety profile for regulatory submissions. By proactively identifying potential concerns, we help reduce unexpected regulatory hurdles.
Biocompatibility Strategy Development
A well-structured biocompatibility strategy is essential to regulatory success. We design and refine customized evaluation plans, selecting the most appropriate testing approach based on device classification, material composition, and intended use. This ensures an efficient, cost-effective process while maintaining full compliance.
Review of Preclinical Data
Regulatory bodies require robust justifications for biological safety. We conduct in-depth reviews of existing preclinical studies, assessing their adequacy to support regulatory submissions and risk assessments. Our team identifies potential gaps and recommends strategies to strengthen the scientific basis of your submission.
Test Plan Coordination
Navigating laboratory testing requirements can be complex. We support clients in defining, selecting, and coordinating biocompatibility testing activities in accordance with ISO 10993 standards. Our experience and knowledge ensure that testing is appropriately designed, efficiently executed, and fully documented to meet regulatory expectations.
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Why Choose CRONET?
Regulatory Expertise
Deep knowledge of ISO 10993 and global regulatory frameworks.
Tailored Solutions
Strategies customized to each device’s unique requirements.
End-to-End Support
From early assessment to final regulatory submission.
Industry Network
Collaboration with certified testing laboratories and experts.