The package development services provided will include:

• Design Inputs
• Risk Analysis
• Material Selection
• Process Development
• Process Validation:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Protocol Development
• Completion Reports
• Sterilization Validation

By integrating the packaging development process earlier into the medical device project we can reduce delays, avoid costly errors, meet or exceed the regulatory compliance requirements and shorten the time to market by months.