ISO 13485:2016 is an internationally recognised standard for Quality Management Systems specifically for the Medical Devices industry. The standard specifies requirements for organisations involved in the design, development, production, installation, and servicing of medical devices and related services.

Organisations certified to this standard demonstrate evidence of a business operation supported by a structured and robust quality management system that ensures medical devices consistently meet customer requirements as well as applicable regulatory requirements.

Certification Process

• Application
  2. Contract Review
  3. Initial Certification (Stage 1 & 2 Audit)
  4. Surveillance Audit
  5. Recertification

What Will ISO 13485:2016 Do For Me?
In the medical device industry, product safety, quality, and regulatory compliance are critical. Implementing ISO 13485:2016 helps organisations establish processes that ensure medical devices are designed, manufactured, and supplied consistently while meeting strict regulatory requirements.

Complying with this standard means your organisation can demonstrate its ability to provide safe and effective medical devices and related services.

In essence, organisations with an effective Medical Device Quality Management System (MDQMS) will be better positioned to meet regulatory obligations, maintain product quality, and ensure patient safety compared to organisations without such a system.

For more information and enquiry, please drop us an email to info@qualiscert.com or call us at +971 58 524 3462