Ingeneus' ISO 13485 accredited, FDA compliant quality systems set us apart from our competitors. Our processes exceed the expectations of regulatory bodies and our clients.

Quality Assurance

Regulatory and Quality Assurance

Examples of our quality services include:

  • FDA compliant and ISO 13485 accredited Product Development and Manufacturing
  • Technical File development and management through the product life cycle
  • Device History Records, allowing capture of pertinent information on every device we build
  • Effective configuration management, guaranteeing that every device is built exactly to customer specifications
  • Change control systems
  • Product tracking providing complete traceability
  • An FDA registered manufacturing facility
  • Post market surveillance systems