Biocompatibility Service

A part of the risk management process is the biological evaluation, which is a design verification activity that is set in the context of the broader risk management process.  BIOTOX Consulting Services, LLC provides biological evaluations in compliance with ISO 10993-1, to support the biological safety of medical devices for your organization.

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BIOTOX Consulting Services can help:

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• Act as a biocompatibility representative with FDA and other regulatory agencies.

• Meet with regulatory agencies on behalf of our clients.

• Prepare biocompatibility documents for Class II and Class III devices for FDA or international regulatory agencies.

• Prepare biocompatibility strategy and gap analyses.

• Prepare biocompatibility justification or waiver memorandum.

• Prepare biocompatibility summary reports.

• Review product and manufacturing changes to ensure there is no biological risk.

• Review protocols and reports that support regulatory submissions.

• Collaborate with your team to support the product release process.

• Communicate to the product development team, biocompatibility requirements and the impact of regulations.

• Manage biocompatibility and analytical chemistry studies.

• Prepare expert biocompatibility reports for regulatory submission.

• Use our knowledge of current domestic and international medical device regulations, to ensure submission requirements world-wide meet the current regulations.

 

BIOTOX Consulting Services, LLC manages the Lifecycle of your risk assessment.  From early-stage development through the approval and commercialization of your product, our consultants can assist with all your needs across the entire product lifecycle.

 

We interface with your team early in the product development process by communicating requirements and the impact of regulations to the development team. We use our expertise to manage and guide the biocompatibility risk assessment, so that you can focus on developing life-changing products.