Services
When you partner with SanaVita Medical, you get first-class medical device processing services to bring innovative solutions to market. Our services extend throughout your product development lifecycle and are perfectly aligned with a vital supply chain.
Project Management:
- Experienced device project management from proof of concept through market launch including manufacturing process development and technology transfer
Biomaterials Analysis:
- Analytical characterization of polymers, biomaterials, and other materials
Inspection:
- Receiving, in-process, and final product inspection and testing
Materials Sourcing:
- Raw materials, components, and packaging
Testing:
- Test method development and validation
- Validated and compendial device test methods
Cleanroom Assembly & Finishing:
- ISO Class 7 and 8 cleanroom finishing and assembly
- Ultrasonic polymer welding
- Surgical needle crimping
- Soldering iron cutting
- Laser cutting and trimming
- Laser cut tip finishing
- Kit assembly
Packaging:
- Validated tray and pouch sealing
- Sterile disposable packaging for implants, devices and instruments to be used in a surgical environment
- Collaboration to obtain custom packaging and pouch design
Label Development & Printing:
- UDI label tracking system with barcoding
- Validated thermal transfer label printing (barcodes)
- Label scanning
Sterilization Management:
- Sterilization and validation support
- Experienced in Ebeam, Gamma and EtO sterilization
Regulatory Support:
- Quality Management System (QMS)
- Device Master Records (DMR) support
- Data and documentation to support regulatory submissions