ISO 13485 Medical Devices – Quality Management System

ISO 13485:2016 helps laboratories to develop or upgrade their Quality Management Systems in Singapore. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Benefits of ISO 13485

  • Cost savings through improved efficiency and productivity
  • Better definition of roles and key responsibilities for employees
  • Systematically provide medical devices and services that consistently meet customer requirements
  • Fulfil regulatory requirements

What can CCIS do for you?

CCIS provides consultancy services to guide your organisation through the stages of development, implementation and trial audit. Contact us today for a non-obligatory quote!