“Important milestone for further development”
CleanNA obtains EN-ISO 13485 certificate
Waddinxveen (NL), March 30, 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.
CleanNA manufactures nucleic acid extraction kits which are based on an easy bind-wash-elute principle using magnetic beads. Their products can be used for extraction of DNA or RNA from clinical samples, or for sample cleanup during PCR or Next Generation Sequencing procedures. The use of magnetic beads makes the products ideally suited for use in automated extraction procedures. CleanNA believes that every scientist should have access to easy and reliable nucleic acid extraction, because it is the essential first step towards important genomic research discoveries and possibly life-saving diagnostic results.