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ISO 13485 Certificate

RAPIvD is certified for complying with the requirements of the quality management system for medical devices - ISO 13485:2016

The certification covers 'Contract development and manufacture of lateral flow assays for IVD' and lasts until November 2025.

The certificate profile can be viewed:

More information about ISO 13485 can be found on the ISO website.

Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485.

Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry. 

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RAPIvD ISO 13485 Certificate
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