Design and Manufacture of Medical Devices (ISO 13485):
ISO 13485:2003 provides the quality management system needed where the ability to provide and manufacture medical devices and related services by an establishment and meet the customers's desires, and regulatory requirements.
Manual
Gap Analysis
Training
Planning
Gap Analysis
Training
Planning
Development and Application
Certification and Managment Review
ISO 13485 is perfect for all establishments providing medical devices, which demonstrates that your products are safe and potent allowing the establishment to the entry to worldwide market and improve costs handling.
