Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
The ISO 13485:2016 standard has been published.
The world’s most recognized quality management system standard for the medical device industry has been revised for the first time since 2003.The standard provides manufacturers, designers, and suppliers to the medical device industry with the framework necessary to demonstrate compliance to regulatory requirements, mitigate risks, and ensure best practices are taken for quality, safety, and sustainability.
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