Regulatory Consulting Services
Biocompatibility Test Failure
We can help determine the cause for a test failure and provide a plan to address the results with written justification and/or alternative testing approaches.
Biological Evaluation Test Strategy Plan
This report, prepared by a toxicologist, will recommend and summarize an ISO 10993 biocompatibility testing strategy, including device details, standards followed, biological endpoints, chemical characterization and other elements, with the intention of increasing your likelihood of regulatory success.
Biological Evaluation Test Summary
This report, prepared by a toxicologist, will summarize the ISO 10993 biocompatibility testing performed, including device details, standards followed, biological endpoints, chemical characterization, etc., and provides an overview of results and device safety under intended clinical use.
Biological Evaluation with Toxicological Risk Assessment
This report includes the Toxicological Risk Assessment and ISO 10993 biocompatibility test results and summary.
Training for technical and regulatory requirements.
A comprehensive review of pre-existing data to identify gaps when compared to current ISO 10993 standards. This report will assess impact and design a plan to address those gaps.
We have a team of experts dedicated to helping our customers execute appropriate studies to meet their needs. An initial consultation will identify project goals and help us understand your product.
FDA Pre-Submission (Pre-Sub)/Q-Submission meetings are an effective way to gain important feedback and expectations for your product and submission strategy. To ensure your meeting is as effective as possible, our team of experts can assist with meeting preparation and are available to participate alongside you in those meetings, either as subject matter experts or to support scientific justifications, strategy or study designs.
Regulatory Inquiry Support
Regulatory and technical support are available to address inquiries from various regulatory agencies (e.g., A.I.’s, remediation, etc.)
Toxicological Risk Assessment
The toxicological risk assessment evaluates the safety of chemicals identified through chemical characterization
For each chemical, tolerable exposure (TE) levels are determined based on relevant toxicological literature and the processes outlined in ISO 10993-17 to support device safety under intended clinical use.
Furthermore, we stand behind the testing we do, and we will support any inquiries related to our studies.