Analytical Services
Medical Devices (implants, drug delivery systems, containers and protective devices)
Cyanta has helped medical device manufacturers from a variety of disciplines including implants, drug delivery systems, containers and protective devices. Our pharmaceutical experience has made us well suited to generate data that will appropriately represent your product to meet the increasing demands of regulatory agencies. We have lent our expertise in all stages from concept development to materials selection through performing the pivotal studies. All areas of experimental design are centered on ensuring product safety, efficacy and stability. Cyanta can support you through the lifespan of your device development program from method development and material selection all the way through to FDA submission support (CDRH).
Our expert Ph.D. staff and project management team can offer:
- Design consultation
- Materials selection
- Compatibility studies
- Stability studies
- Extractable/Leachable and Migration studies
- Development and Validation
- Physical testing (Failure analysis, stress-strain and adhesive strength)
- Photo- and Thermo-set polymer systems
- Device Comparison Studies
- Familiar with ISO / FDA / ASTM / USP testing
