ISO 13485

ISO 13485 is an international standard that specifies quality management system (QMS) requirements specifically for medical devices and related services. It is designed to enable medical device manufacturers to demonstrate their ability to provide safe, high-quality products that comply with applicable regulations in various countries.

Benefits of ISO 13485

• Increase customer and business partner trust.

• Open global market access, often a mandatory requirement for medical device exports.

• Minimize the risk of defective or hazardous products.

• Improve process efficiency through documented and controlled work standards.

In short, ISO 13485 is key for medical device companies to ensure quality, comply with regulations, and compete in the international market.

Main Focus of ISO 13485

• Product Quality & Safety – ensuring medical devices are consistently manufactured and safe for patients.

• Regulatory Compliance – helping companies meet international legal requirements, such as the FDA (US), CE Marking (Europe), and BPOM/Ministry of Health (Indonesia).

• Risk Management – ​​managing potential risks from the design, production, distribution, and post-marketing stages.

• Traceability – rigorous documentation to track every component and production process.