What is ISO 13485 Certification?

ISO 13485 specifies the requirements for a quality management system that any organisation operating in the medical devices sector needs to demonstrate. Certification demonstrates your organisation’s reliability, proving your commitment and abilities to provide design, manufacturing, testing and sales services that consistently meet customer needs and regulatory requirements.

Getting certified with Kiwa

With increasingly strict regulatory requirements and expectations from customers and organisations throughout the supply chain, it is critical to demonstrate best practice in quality management processes – and ISO 13485 certification can do that.

By partnering with Kiwa, you can use ISO 13485 to ensure the products or services you offer in the medical devices field are in accordance with internationally accepted standards, helping you build trust with customers and meet legal requirements.

ISO 13485 and the MDR

The ISO 13485 quality standard helps suppliers of medical devices and related services comply with the Medical Devices Regulation (MDR). Kiwa UK co-operates with Kiwa Dare, Kiwa Cermet Italia and Kiwa Belgelenddirme Hizmetleri who are able to provide services for EU MDR. 

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