ISO 13485:2016 - Quality Management System for Medical Devices

ISO 13485 is a standard for quality management systems in the provision of medical devices and related services. With this standard, relevant organizations can ensure that the production, storage, distribution, installation, servicing, and development of medical devices, as well as related activities, are carried out effectively.

Benefits of Implementing
ISO 13485:2016 - Quality Management System for Medical Devices

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Ensuring optimal work standards for sustainable company growth.
Demonstrating compliance with customer requirements and applicable regulations.
Capable of effectively communicating responsibilities and delivering positive messages to staff and customers.
Able to improve the efficiency and effectiveness of the production, storage, distribution, installation, servicing, and development of medical devices
Able to provide related technical activities and facilitate external parties in the provision of medical equipment.

Undang-Undang (UU) Number 17 of 2023 concerning Health.
Government Regulation (PP) Number 72 of 1998 concerning the Security of Pharmaceutical Preparations and Medical Devices.
Minister of Health Regulation Number 3 of 2020 concerning the Classification and Licensing of Hospitals.
Comply with Indonesian National Standard (SNI) Regulations.