ISO 13485 provides a tailored QMS framework for organizations involved in the lifecycle of medical devices. It covers processes from design and manufacturing to distribution and post-market activities, ensuring compliance with regulatory and customer requirements.
The standard emphasizes risk management, effective communication, and process controls to maintain product quality. By implementing ISO 13485, organizations enhance their credibility and ensure safe and effective medical devices for end users.
Including
1
gap assessment audit
2
procedures and forms preparation
3
implementation
4