ISO 13485:2016
Medical Devices Quality Management System
GMP / CPAKB
Good Manufacturing Practices for Medical Devices
ISO 11135:2014
Sterilization of Health Care Products
Quality
Flawless & efficient product design, which results in high quality product standard.
Comprehensive
Comprehensive compliant data from product development to production stage.
Cost
Cost efficient process .
Regulatory
Strong technical data which is easily adopted for meeting regulatory requirement.
Transparent
Transparent cost component to facilitate healthy return for product owner.
Experience
Experienced personnel with strong knowledge in medical and healthcare industries.
Certification
ISO 11135:2014
Ethylene Oxide – Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 13485:2016
Medical Devices Quality Management System
GMP / CPAKB
Good Manufacturing Practices for Medical Devices (Cara Pembuatan Alat Kesehatan yang Baik)
Assembly of electrical medical equipment
Manufacturing of consumable medical devices.
Primary and secondary packaging.
