Medical Device Risk Assessment

Medical Device Risk Assessment

The Toxicological Risk Assessment (TRA) is an important tool in the safety assessment of biomedical devices, providing a chemical-based approach which complements a traditional animal-based testing program. The need for TRA is growing and in some cases, may be considered as a means of circumventing animal testing in the safety evaluation of devices.

The objective of TRA for medical devices is to evaluate the potential health risks associated with exposure to leachable impurities, contaminants, or other residues in or on the device.  Devices can span a broad range of products, from drug delivery systems to implanted stents. Container closure systems (CCS) are also evaluated as medical devices with the drug formulation being the exposure medium.  In the case of medical devices, the TRA is based on the data from a chemical characterization, and the TRA is aimed at making a determination as to whether the release of chemicals during the use of a medical device may represent a toxicological risk that is unacceptable from a regulatory perspective.

 

Service Offerings 

 

Regulatory Guidance

  • ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process

  • ISO 10993-17: Biological Evaluation of Medical Devices - Part 17: Establishment of Allowable Limits for Leachable Substances

  • ICH Q3D. 2015: Elemental Impurities: Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)

  • ICH M7. 2015: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Guidance for Industry

  • ISO 14971, 2007: International Standard. Medical Devices- Application of Risk Management to Medical Devices. Second Edition. Reference Number ISO 14791:2007(E)

    ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications

 

ToxSmart Technical Expertise  

ToxSmart utilizes publicly-accessible research tools on the internet, including search engines and on-line toxicology databases. Computer-aided programs in quantitative structure-activity relationships (QSAR) are also utilized as needed and Toxikon uses the CASE Ultra program (MultiCase, Inc., Beachwood, OH) and other publicly-accessible programs, including ToxTree™ and the OECD Toolbox.

 

White Paper

Download this educational white paper to learn more about toxicological risk assessment. 
 
FDA Finalizes Guidance on Medical Device Safety Evaluation
 
Medical Device Risk Assessment
Medical Device Risk Assessment, Risk Assessment, Toxicological Risk Assessment, Gap Analysis, Regulatory Strategy, Raw Material Safety Investigation, 510(k) Submission Support
The Toxicological Risk Assessment (TRA) is an important tool in the safety assessment of biomedical devices, providing a chemical-based approach which complements a traditional animal-based testing program. Contact Toxikon today for Medical Device Risk Assessment evaluation services guided ISO 10993-1, 10993-17, ICH Q3D, ISO 14971, and ISO 18562.