How do you ensure the safety and efficacy of medical devices during the clinical testing phase?

Sample interview questions: How do you ensure the safety and efficacy of medical devices during the clinical testing phase?

Sample answer:

• Adhere to Regulatory Standards:

  • Comply with ISO 14155 (clinical investigation of medical devices) and other applicable regulations.
  • Maintain rigorous documentation and quality control systems to ensure compliance.

• Conduct Thorough Preclinical Testing:

  • Evaluate the device’s safety and functionality in animal models and lab studies.
  • Characterize potential risks and determine the appropriate test population.

• Design Clinical Trials with Careful Selection and Monitoring of Participants:

  • Include a diverse study population representing the intended users.
  • Implement strict inclusion/exclusion criteria to identify suitable candidates.
  • Monitor participants regularly for adverse events and device performance.

• Implement Risk Management Plan:

  • Develop and maintain a comprehensive risk management plan to identify, assess, and mitigate potential risks.
  • Track and analyze data to identify potential safety concerns and take appropriate actions.

• Provide Training and Support to Investigators:

  • Train clinical trial staff on pr… Read full answer

    Source: https://hireabo.com/job/2_3_22/Biomedical%20Engineer