GalileoAuto has successfully achieved ISO 13485:2016 certification for our medical device seal assembly solutions, demonstrating our commitment to quality management systems specific to the medical device industry.

What This Means

The ISO 13485 certification ensures that our:

• Design and development processes meet medical device regulatory requirements
• Manufacturing facilities maintain appropriate cleanliness standards
• Quality management system supports traceability and risk management
• Documentation and validation processes comply with FDA and EU MDR requirements

Benefits for Medical Device Manufacturers

Our certified solutions provide:

• Complete data traceability for regulatory submissions
• Validation documentation packages (IQ/OQ/PQ)
• Cleanroom-compatible equipment designs (Class 100)
• Risk assessment and mitigation support

This certification reinforces our position as a trusted partner for precision medical device manufacturers worldwide.