Services

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 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