Medical Devices

Biocompatibility, Safety Assessment and Regulatory Affairs

  • Leachable and extractable design and risk assessment
  • Materials qualification / Biocompatibility
  • Study protocol design
  • Impurity and degradant qualification
  • Study placement, monitoring, report preparation/review
  • Clinical safety studies
  • Expert Reports
  • Position Papers
  • Technical Writing
  • Full information services support
  • Combination Products
  • Changes to material, supplier or manufacturer