Services

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