Quality is built into our manufacturing processes from the start, beginning with product development. Along the way, we continually monitor and update our processes in order to adhere to strict quality standards and assure flawless compliance. Our capabilities for medical device manufacturing include:
- ISO 13485:2003
- FDA 21 CFR 820
- ISO Class 7 and 8 clean rooms
- Quality management
- Technology transfer
- Qualification and validation activities
- Test method development and validation