ISO 13485:2016

Medical Devices Quality Management System

GMP / CPAKB

Good Manufacturing Practices for Medical Devices

ISO 11135:2014

Sterilization of Health Care Products

Why choosing us

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.

Vision

Creating values for the people, spreading wellness to the world

 

Mission

We strive to become a one stop solution partner for medical devices realization and its supporting properties.
We deliver high quality products and excellent services in order to achieve customer satisfaction and spread benefits to consumers

 

Our Values

Our Passion, Commitment, and Integrity will deliver Compliance and Excellence through Empowerment

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)

Quality Policy

 

  • Quality is the foundation of our products and services

  • Quality is mandatory to ensure customer’s safety and well- being

  • Quality is everybody’s commitment

 

Our production facility is featured with controlled room for :

 

Assembly of electrical medical equipment
Manufacturing of consumable medical devices.
Primary and secondary packaging.
Adjacent to Ethylene Oxide Sterilization facility

Our laboratory runs based on ISO 17025:2017.

The laboratory is in conjunction with sterilization process