Our products are quality assured and CE marked allowing for free movement and sale across the European Economic Area through successful compliance to ISO 13485:2012 Quality Management System for Medical Devices, by internationally recognised Notified Body TÜV Rheinland.
We are registered with Malaysia’s Medical Device Authority for both our products and business establishment.
All processes and materials used in the manufacturing of GA2 Medical products meet both local and international standards.
In order to maintain the highest quality standards, we will:
- Establish and maintain a quality management system in accordance with EN ISO 13485:2012.
- Set objectives and measurable targets so that quality performance can be measured and continually improved.
- Provide adequate resources to achieve the objectives and targets of our quality system.
- Foster a quality culture with the aim of minimising undesired effects in our products.
- Encourage participation and promotion of quality culture in our employees through training, education, coaching and effective communication.
- Comply with all relevant laws and regulations, as well as internal requirements.
- Maintain a quality policy that is appropriate to the context of the organisation and supports its strategic direction.
The company is determined to continuously upgrade their management and technical capabilities in order to stay competitive at all times.