ISO 13485 Medical Devices – Quality Management System
ISO 13485 specifies requirements in Malaysia for a Quality Management System that can be used by an organisation in Malaysia involved in one or more stages of the life-cycle of medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning, disposal of medical devices, and provision of associated activities in Malaysia.
Medical devices are required to meet certain regulations to be distributed to medical industries of Malaysia. A quality certificate that can assure you are producing and selling devices that are safe is the ISO 13485.
Internationally recognised and accepted, the ISO 13485 is a necessary certification in Malaysia if you are looking to improve performance and remove any uncertainty in your business. Suitable for medical device industries, this certificate requires you to specific requirements.
ISO 13485:2016 helps laboratories to develop or upgrade their Quality Management Systems in Malaysia.
ISO 13485 is the leading ISO Consultants in Malaysia in handling Medical Devices and Quality Management.
BENEFITS OF ISO 13485 in Malaysia
- Trust in being a safe supplier and producer
- Likelihood of meeting customer requirements and expectations
- Reduce operation cost and production loss rate
- Improve processes based on objective measurement
- Increase competitive advantage
- More effective risk management
- Better definition of roles and key responsibilities for employees