ISO 13485 Services in Malaysia

ISO 13485 Services

What is ISO 13485?

ISO 13485 is an international standard that specifies the requirements for a comprehensive quality management system (QMS) for the design and manufacture of medical devices. It is intended to help organizations demonstrate its ability to consistently meet customer and applicable regulatory requirements in the manufacture of medical devices. Some of the key elements the standard focuses on are management responsibility, control of the work environment, risk management, analysis and improvement.

Who Needs ISO 13485?

In Malaysia, all medical device manufacturers must be ISO 13485 certified prior to obtaining an establishment licence from the Medical Device Authority, MDA. ISO 13485 certification is also a requirement for product registration with MDA. As a medical device manufacturer, you have a responsibility to consistently deliver devices of high quality and that are also safe and efficacious.

Benefits of ISO 13485

Achieving ISO 13485 certification demonstrates that your company is committed to quality and meets international regulatory requirements for medical devices. It improves your company’s credibility, image, processes, and customer satisfaction whilst at the same time fosters a culture of continuous improvement. All these contribute towards increasing customer satisfaction and confidence in your company and products.

The Process for Obtaining ISO 13485 Certification

Understand the ISO 13485 requirements
Develop and implement an ISO 13485 QMS to meet the requirements
Conduct an internal audit to ensure the ISO 13485 QMS is being followed
Have your ISO 13485 QMS audited by a Conformity Assessment Body (CAB)
Obtain the ISO 13485 certificate
Apply for the MDA Establishment Licence for Manufacturer

Talk to Us

Appointing the right consultant is key to your success with an ISO 13485 QMS. At Cubic Life Sciences, we can help you identify and mitigate risks associated with the design, development and production of medical devices with the ultimate aim of improving processes and increasing efficiency, leading to better products and higher customer satisfaction. We have a team of experienced professionals who possess the necessary expert knowledge to help you create an efficient ISO 13485 QMS that minimises complexity but complies with ISO 13485 requirements.

Malaysia Consulting Service for ISO 13485

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