Toxicology Service

The potential toxicity of materials, components and their route of exposure is an important part of the biological risk assessment process.  BIOTOX Consulting Services, LLC provides toxicological risk assessments in compliance with ISO 10993-17,to support chemical characterization of medical devices for your organization.

 

BIOTOX Consulting Services can help:

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

• Meet with regulatory agencies on behalf of our clients.

• Prepare toxicological risk assessments for Class II and Class III devices for FDA or for international regulatory agencies.

• Collaborate with your team to support your company’s product release process.

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

• Develop and review study protocols.

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

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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.

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We interface with your team early in the product development process by preparing exposure assessments and performing risk assessments. We use our expertise to manage and guide the toxicological risk assessment, so that you can focus on developing life-changing products.