ZeptoMetrix, a trusted name in the field of infectious disease diagnostics, announced the attainment of the IVDR Quality Management System certificate from British Standards Institution BSI, NB 2797. This certification marks a significant achievement, positioning ZeptoMetrix as a frontrunner in compliance with the new EU In Vitro Diagnostics Regulation (IVDR).

The certificate encompasses a substantial portion of ZeptoMetrix’s extensive portfolio of CE marked NATtrol quality control products. These products hold the distinction of being the industry’s preferred brand for molecular diagnostic testing, offering healthcare professionals ready-to-use, independent third-party quality control materials. As part of the certification process, ZeptoMetrix will be focusing on updating its product labeling over the next several months.

Elevating Quality Commitment

Glenn Harrall, Global Vice President of Quality at ZeptoMetrix, expressed satisfaction with the seamless transition to IVDR, highlighting the company’s ongoing dedication to quality programs and regulatory compliance. Harrall emphasized that this milestone reflects ZeptoMetrix’s unwavering commitment to its partners and customers, ensuring they receive top-notch quality control solutions.

Supporting European Clinical Laboratories

Evangeline Gonzalez, President of ZeptoMetrix, emphasized that achieving this certification milestone further underscores ZeptoMetrix’s commitment to providing European clinical laboratories with dependable and innovative quality controls. ZeptoMetrix’s reputation for delivering reliable solutions, including external quality controls, verification panels, proficiency panels, customized products, and OEM services, sets the industry standard for performance and reliability. This distinction solidifies ZeptoMetrix as the preferred choice for independent third-party quality control materials.

As an integral part of the Antylia Scientific family, ZeptoMetrix continues to lead the way in designing, developing, and delivering high-quality solutions to the infectious disease diagnostics market. Their unwavering expertise and dedication to excellence make them a go-to resource for healthcare professionals seeking reliable and innovative diagnostic solutions.

  Evangeline Gonzalez, Glenn Harrall, ZeptoMetrix