Industry News: Important milestone for further development

CleanNA obtains EN-ISO 13485 certificate

31 Mar 2023

CleanNA, a Dutch manufacturer of magnetic bead-based nucleic acid extraction kits, has been certified EN-ISO 13485 by Bureau Veritas Certification. The company’s quality management system meets the requirements of this international standard for medical devices and research use only products, in their case for the design and manufacturing of magnetic particle-based reagents, kits, and accessories, for purification and isolation of nucleic acids used for molecular diagnostics and research.

Quality is hugely important in the medical device industry. Products used for diagnostic procedures need to be manufactured in a way that assures complete product traceability, consistency, and reproducibility, fit for the purpose they were designed for. The EN-ISO 13485 standard supports companies in maintaining a quality management system that meets both these customer demands, as well as applicable regulatory requirements. Being EN-ISO 13485 certified means having controlled company processes that are continuously developed and improved. CleanNA customers can expect consistent quality of products, clear processes and reliable customer support.

“EN-ISO 13485 certification is an important milestone for the further development of CleanNA as a medical device manufacturer. We are extremely proud of our CleanNA team, who all contributed to make this possible. We look forward to establish further customer collaborations, and develop IVD products for the growing diagnostic market.” – Moniek Kors, COO of CleanNA.

Now that CleanNA is EN-ISO 13485 certified, the company will remain focused on continuous improvement, ensuring customer satisfaction. EN-ISO 13485 is an ongoing process and the company will be audited yearly to ensure compliance. Working according the requirements of EN-ISO 13485 also helps CleanNA to achieve its next goal: launching CE-IVD certified products that can be used in diagnostic workflows. Obtaining the EN-ISO 13485 certificate marks the starting point of CleanNA’s journey into the molecular diagnostics market.

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