White Papers

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.

 


Biocompatibility 

Sample Preparation of Medical Devices for Biocompatibility Testing

  • Have a better understanding of evaluating a medical device or material and learn process of sample preparation. 

 

Points to Consider in ISO 10993 Testing

  • Which evaluations to perform as well as how to perform these tests are governed by what is called the International Standardization Organization (ISO) 10993 series of standards.

 

Sub-acute, Sub-chronic and Chronic Systemic Toxicity Testing of Medical Devices

  • Importance of applying drug and chemical test methodologies to biocompatibility testing.

 

Considerations for Canine Thrombogenicity Test (ISO 10993-4)

  • Test method that address FDA expectations, practical considerations, and inherent limitations of the canine thrombogenicity test.

 

Biocompatibility Safety of Medical Devices: FDA, ISO, and Japanese Guidelines

  • Amid efforts at harmonization, important differences exist between U.S./FDA/ISO and Ministry of Health, Labour, and Welfare (Japan) medical device biocompatibility requirements.

 


Toxicology Consulting Risk Assessment

FDA Finalizes Guidance on Medical Device Safety Evaluation

  • Achieve a better understanding of biological safety evaluation and answer questions related to what you should be doing as a device manufacturer to comply with FDA guidance while keeping your overall program costs manageable. 

 


Extractables and Leachables

Identifying Unexpected Impurities in Drug Products: A Challenging Task

  • Learn how to behave unexpected impurities that suddenly arising in e.g. a QC analysis, may create a lot of stress and anxiety within different departments of a pharmaceutical company. 
White Papers
medical device testing, pharmaceutical testing, safety testing, efficacy testing, drug development, best practices, white papers, case studies, education
Toxikon's scientific staff 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.