Testing Strategy & Evidence Planning

  • Testing matrix recommendation and gap analysis
  • Performance test design aligned with FDA-recognized standards
  • Sterilization, shelf-life, packaging, and usability testing strategy
  • CRO engagement support and report adequacy review
  • Labeling review: FDA requirements, UDI compliance (21 CFR Part 830), and IFU review
  • Applicable consensus standards mapping and Declaration of Conformity
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