Medical Devices (implants, drug delivery systems, containers & protective devices)
Azopharma has helped medical device manufacturers from a variety of disciplines. 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. Azopharma will support you through the lifespan of your device, beyond development, and will assist with approval submission to FDA (CDRH).
Our expert Ph.D. staff and project management team can offer the following:
- 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