Anders have today announced they 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 their ongoing commitment to deliver high-quality and reliable technology that meet or exceed regulatory requirements for their 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 the organisation’s commitment to provide products and services that meet the stringent demands of the medical industry.

What This Means for Medtech Companies

This certification provides assurance of quality, safety, and compliance. Whether you are developing advanced medical displays, embedded systems, or custom HMI solutions, ISO 13485 accreditation means:

  • Regulatory Confidence: Anders’ processes align with global medical device regulations, reducing compliance risks and ensuring smoother approvals.
  • Enhanced Product Reliability: Anders’ 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, Anders uphold the highest industry standards, enabling seamless integration into your medical device manufacturing processes.
  • Continuous Innovation & Improvement: Anders’ dedication to quality extends beyond compliance; they are committed to refining their 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 Anders capabilities in medical technology, please visit www.andersdx.com.