White Papers

Our distinguished scientific staff not only fully understand medical device and pharmaceutical product testing requirements; they help create them. Key Toxikon staff are contributors to the professional panels and organizations that define industry best practices and influence regulation and legislation.

The study directors, scientists, and technicians working on your testing programs regularly share their collective knowledge through white papers, case studies, and conference presentations. We’re pleased to share these educational resources with you; collaborating on education and best practices will lead to better products and, therefore, improved quality of life for patients worldwide.


  • Sub-Acute, Sub-Chronic, and Chronic Systemic Toxicity Testing of Medical Devices

    This white paper examines the interpretation of the ISO 10993 guidelines for sub-acute, sub-chronic, and chronic systemic toxicity testing of medical devices. It suggests study designs from the pharmaceutical industry that are compliant with ISO 10993 and could result in better quality test conditions, more accurate data, and overall acceptance.

  • Sample Preparation of Medical Devices for Biocompatibility Testing

    Biocompatibility testing is an essential part of receiving regulatory approval for medical devices. While the testing itself is important, the correct preparation of samples used for testing is equally as important. Below you will learn about the many requirements and factors that must be considered when preparing samples for accurate biocompatibility testing.

  • Considerations for the Canine Thrombogenicity Test

    This white paper proposes a test method that addresses FDA expectations, practical considerations, and inherent limitations of the canine thrombogenicity test. It discusses the history of the test, considerations when initiating the test, standard methodology, and evaluation criteria.

  • Biocompatibility Evaluation Of Honey-Based Medical Devices

    Contemporary regulations surrounding natural products have grown in scope and complexity, as both regulatory agencies and consumers demand assurances that ‘natural’ medical products in the market are safe. With these considerations in mind, honey-derived or honey-containing medical products should receive the full battery of biocompatibility evaluations to ensure patient safety.

Ocular Studies