ISO13485 Certified: Quality in Medtech Design

We are delighted to announce that we have been awarded ISO 13485 certification, a globally recognised standard for quality management systems in the design and manufacture of medical devices. 

This certification marks a significant milestone in our ongoing commitment to deliver high-quality and reliable technology that meet or exceed regulatory requirements for our medical customers.

What Is ISO 13485?

This internationally accepted standard covers all aspects of a product’s lifecycle, from initial design and development through production and distribution.

It ensures strict adherence to regulatory requirements, risk management protocols, and continuous improvement processes. Achieving this certification underlines our commitment to provide products and services that meet the stringent demands of the medical industry.

What This Means for You

Whether you are developing advanced medical displays, embedded systems, or custom HMI solutions, this certification provides assurance of quality, safety, and compliance. 

• Regulatory Confidence:
  Our processes align with global medical device regulations, reducing compliance risks and ensuring smoother approvals.
  
  
• Enhanced Product Reliability:
  Our commitment to rigorous quality systems and controls translate into robust, high-performance products designed for critical healthcare applications.
  
  
• Supply Chain Assurance:
  As a trusted partner, we uphold the highest industry standards, enabling seamless integration into your medical device manufacturing processes.
  
  
• Continuous Innovation & Improvement:
  Our dedication to quality extends beyond compliance; we are committed to refining our processes and technologies to better serve the evolving needs of the medical sector.

"ISO 13485 certification reinforces our commitment to quality and compliance. It’s another major step in ensuring our medical technology solutions are safe, reliable, and have been designed and manufactured to the highest standards, from concepts through to reality." Bernard Lim, Chair

For more information about our capabilities in medical technology, please get in touch with our team today.