ISO 13485 Medical Devices Consultant & Training Singapore
Number of companies who have benefited from our services for ISO & bizsafe
Why is the ISO 13485 certification necessary?
The medical devices industry is one of the most highly regulated sectors globally, so it must demonstrate compliance with regulatory and product requirements to ensure the safety and performance of medical devices produced. To be distributed to medical industries, medical devices are required to meet the internationally recognised ISO 13485 standard. This is to ensure the safety and quality of your medical devices.
ISO 13485 Medical Devices – Quality Management System
ISO 13485:2016 helps laboratories to develop and upgrade their Quality Management Systems in Singapore. It specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Benefits of ISO 13485:2016
Necessary for companies that require management systems, the ISO 13485 focuses on risk management, controlling the workplace environment and promoting awareness of quality management. The ISO 13485 certification brings companies many benefits, including:
- Cost savings through improved efficiency and productivity
- A better definition of roles and key responsibilities for employees
- Systematically providing medical devices and services that consistently meet customer requirements
- Fulfilling regulatory requirements
What can CCIS do for you?
Whether you’re looking to grow your brand or want to increase the security of your management system, this ISO 13485 certification is a necessary step for all organisations that specialise in medical tools. Our team is knowledgeable in all ISO documents and auditing processes, so we will be able to assist you with any questions you have.
Contact CCIS today
CCIS provides consultancy services to guide your organisation through the stages of development, implementation and trial audit. Unsure about whether you need this certification? Contact us today and let our professional ISO consultants assist you.