Expert Guidance for Biocompatibility, Toxicology, and Material Sciences
FernaTek Solutions provides end-to-end biocompatibility, toxicology, and materials science services to medical device companies seeking to demonstrate biological safety of their devices for regulatory approval and market clearance.
ABOUT
Navigating testing requirements can be complex and often presents obstacles on the road to regulatory clearance. From strategic planning to final reporting, our comprehensive services guide you through the process efficiently and effectively.
Rather than taking a checklist approach, we work closely with clients to develop a tailored strategy for each product.
By collaborating with product development teams early on, our experts identify potential gaps and risks. We then develop strategic plans to minimize compliance deficiencies. Our rigorous risk management approach aims to maximize successful outcomes for each project.
WHAT WE DO
Strategic Consulting
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Provide expert consulting and guidance on overall strategy and approach for new products, device and material changes, manufacturing changes, and manufacturing location changes.
Biocompatability Testing
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Develop biological evaluation plans consistent with different regulatory bodies (FDA, EU-MDR, PMDA, NMPA, etc.) and compliant to ISO 10993 guidelines.
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Assist with identifying testing labs.
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Design testing plans and protocols.
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Coordinate with testing labs and Contract Research Organizations (CRO).
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Review biological testing reports for accuracy, thoroughness and compliance.
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Prepare biological evaluation reports.
Chemical Characterization
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Provide expert consulting on chemical characterization (CC) strategy.
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Assist with identifying testing labs.
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Develop CC testing protocols and coordinate testing with labs/CRO.
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Review CC data and reports for accuracy, thoroughness and compliance.
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Analytical method development and validation
Toxicology Services
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Provide expert toxicological consulting.
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Prepare toxicological risk assessments.
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Chemical-specific toxicity assessments.
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Toxicity equivalency analyses.
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Device contaminant assessment.
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Calculation of toxicity-based safe levels of identified compounds.
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Assessments of manufacturing/cleaning practices.
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Comparative analyses of manufacturing chemical options.
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Review previously generated risk assessments for gaps and thoroughness.
Regulatory Support
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Knowledge and expertise on global regulations relating to biocompatibility.
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Generate gap assessments when standards and guidance documents are revised.
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Interact with regulatory bodies.
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Respond to deficiency questions from regulatory bodies.
Due Diligence & Quality Control
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Can assist with due diligence activity by reviewing and providing expert opinion on relevant activities and documentation.
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Can lead or assist with auditing of testing labs.