Risk Assessments

Risk analysis is used for the evaluation of potential risk problems that could be encountered in connection with the use of a medical device. Biological hazards, risk characterization, and toxicological risk assessment are required to ensure the safety of a novel medical device and meet the requirements of marketplaces.

Standard for Risk Assessments

Risk assessments are instructed by FDA regulations and international standards. FDA Final Guidance solidified the role of toxicological risk assessment (TRA). TRA and chemical characterization are described as prerequisite to biocompatibility testing.

"Biological Safety Assessment", part of the biological evaluation of medical devices standards(ISO 10993-1), gives out the general considerations that should be taken into account when evaluating and testing medical devices within a risk management process.

"Toxicological Risk Assessment", part of the biological evaluation of medical devices standards( ISO 10993-17), establishes allowable limits for leachable substances and provides direction to ensure adequate testing and appropriate evaluation of safety.

The general procedure of the risk assessment approach is testing physical and characterization; followed by the assessment of toxicological risks, and use the results to focus/ limit the scope of biological testing.

Testing Capabilities

• Toxicological Risk Assessment

  Our team will help you to use identified compounds and relevant biological testing to balance risks with the clinical benefit to the patient.

  • Hazard identification

    - Chemical characterization

    - Toxicological characterization

  • Dose-response evaluation

    - Drive tolerable exposure levels

    - Extrapolation of animal data

    - Different routes of administration

    - Different study durations (subacute vs. chronic)

  • Exposure assessment

    - Categorize the device: Nature of contact

    - Categorize the device: Frequency/duration of use

    - Describe the use of device/ product, i.e., nature and magnitude of patient contact, patient population

  • Risk characterization

    - Explain uncertainties, margins of safety

    - Demonstrate therapeutic benefits of the medical device

• Biological Evaluation Plan

  A Biological Evaluation Plan (BEP) is an initial risk assessment for medical devices. The general considerations for the BEP take into account are the nature and duration of body contact, the selection and materials of construction, manufacturing processes, the biological endpoints of concern, and the historical use of the device. BEP supports a strategy to address areas of remaining biological risk, which may include both chemical and biological testing.

• Biological Evaluation Report (BER)

  Our experts will help you to determine:

  - Biological evaluation of the medical device;

  - The acceptability of the material for the intended purpose; the risk management plan;

  - Material characterization;

  - The interpretation of data and results;

  - Additional data for the biological evaluation;

  - Biological safety conclusion.

• Equivalency Assessment

  Equivalency assessment is used to evaluating the equivalency of a device to another marketed product. Equivalency testing is generally conducted based on data and properties for clinical and biological parameters, methods of use, materials as well as equivalent clinical and biological properties performance.

• Gap Analysis

  Evaluation of changes in regulatory standards under which the previous testing was performed compared to the most current regulatory standards.

  This typically includes:

  - Review of each standard identified in the request

  - Review of testing performed previously

STEMart offers risk assessments services following the biocompatibility guidelines modified for medical devices. If you have additional questions about Risk Assessment or would like to find out more about our services, please feel free to contact us.