Medical Device Testing Guide

Our Medical Device Testing Guide is an overview of testing requirements for standard ISO, MHLW, and USP compliant studies. The guide features directions for sample submission, test requirement matrix for FDA/ISO/Japanese guidelines, as well as test descriptions, estimated sample requirements, and turnaround times for individual studies.

Available Medical Device Tests

  • ISO Tests
  • MHLW Biocompatibility Tests
  • USP Compendial Tests
  • Microbiology Tests

Standards

  • ISO 10993
  • United States Pharmacopeia (USP)
  • European Pharmacopeia (EP)
  • Japanese Ministry of Health, Labor, and Welfare (MHLW)
  • Japanese Pharmacopeia (JP)