ISO 13485 System Implementation
Stage 1 Audit - Documentation Review
Stage 2 Audit - Site Audit
Certification of ISO 13485 System
Establishment License Registration with Medical Device Authority

Quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities.

  • Specifically tailored for the medical devices industry to demonstrate its ability to systematically provide medical devices and services that consistently meet customer requirements, meet applicable regulatory requirements and safety standard.
  • Provides a systematic approach to risk management.
  • Systematic, smoother, transparent and documented handling of activities required by regulations such as post market follow up and surveillance, complaints handling, process validation, product recall handling, vigilance etc.

Medical Device Authority, Ministry of Health Malaysia


The requirements in this International Standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations.