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Safety & Performance Evaluation

(1) Safety Evaluation

  • Establishing medical device design and development procedures , risk management (ISO 14971:2019) procedures, along with templates of related forms.
  • Biocompatibility risk assessment on body-contacting parts of the product (including mock review of related third-party testing reports).
  • Systemic electrical safety and EMC risk assessment including mock review of related third-testing reports.
  • Device software and firmware risk assessment, design verification, SRS, SDS, system architecture validation (in accordance with IEC 62304, FDA Device Software Functions regulatory guidance, IEC TR 80002-1:2009, FDA Cybersecurity regulatory guidance)
  • Software and firmware failure mode effect evaluation, threat modeling, and cybersecurity related risk assessment.
  • Planning for risk control measures related to all levels of the system architecture.
  • AI/ML algorithm risk assessment and design verification (in accordance with FDA AI/ML SaMD regulatory guidance, AAMI CR34971:2022).
  • Device and system GUI usability and human factors engineering evaluation and testing (in accordance with IEC 62366 and FDA Usability regulatory guidance)
    • Consolidation of use specifications (according to intended use and clinical indication structure, users, use environment and other requirements) and user interface specifications
    • UI task analysis, cognitive walk through and heuristic analysis to define critical tasks and risk factors/use errors (such as Cognition, Perception, Action Related Use Errors), and formulate a risk control plan
    • Conduct usability formative study to verify the usability of the user interface and instruction for use in the Design Verification stage and the effectiveness of the risk control plan

(2) Performance Evaluation

  • Device and system GUI usability and human factors engineering evaluation and testing (in accordance with IEC 62366 and FDA Usability regulatory guidance):
    • Conduct a usability summative study (Usability Summative Study) to validate the usability of user interface and IFU in the design stage and the effectiveness of the risk control plan.
  • Product preclinical performance evaluation and design, based on:
    • FDA AI/ML SaMD & Device Software Functions regulatory guidance,
    • FDA cybersecurity regulatory guidance,
    • Preclinical product performance test standards and performance comparisons of predicate devices proposed by the team
  • Product clinical performance and design evaluation, based on:
    • IEC 60601-1
    • IEC 82304-1
    • FDA AI/ML SaMD regulatory guidance
    • FDA Device Software Functions regulatory guidance
    • IEC 80601-2-61
    • Performance comparison of agreement analysis between the product and its predicate
    • Clinical Guideline based on available clinical guidelines

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Contact

Tel：+886-3-666-0139
Fax：+886-3-666-0149
Email: services@seqpro.com.tw