Medical Device Medical Device

Medical Device



Medical Device

Pharmaseed offers turn-key solutions and consulting services that covers all the necessary steps needed from proof-of-concept to first-in-man. The experienced and dedicated team will ensure that expenses and time are minimized while validation process is maximized. This enables the developing sponsor to focus their efforts on successful development.

 

Pharmaseed’s Anatomy Unit

 

Evaluation Tests For Surface and Implant Medical Devices (FDA G-95)

 

Premarket Approval

 

Biocompatibility evaluation capabilities:

  • Cytotoxicity (Tissue Culture)
  • Sensitization Assays
  • Irritation Tests
  • Acute Systemic Toxicity
  • Subchronic Toxicity
  • Genotoxicity
  • Implantation Tests
  • Hemocompatibility
  • Carcinogenesis Bioassay
  • Reproductive and Developmental Toxicity
  • Pharmacokinetics
  • Preclinical Safety Testing
  • Histopathology Services

 

For more information on how we can help you
move your drug or device along the development pathway.
Contact Us