We are excited to share that NewBio has successfully passed our QMS recertification audit, resulting in the renewal of our ISO 13485 and MDSAP certifications, now valid until 2027. Alongside our IVDR certification for TPHA and RPR products, this milestone reaffirms our commitment to delivering high-quality diagnostic products. These certifications not only ensure compliance with EU and UK standards but also demonstrate that our QMS meets regulatory requirements in Australia, the US, and Canada, providing our customers with continued confidence in our products and services.
Read More »The Instructions for Use for all of our products are now available to download on the Quality and Accreditations page.
Read More »The Safety Data Sheets for all of our products are now available to download on the Quality and Accreditations page.
Read More »We are very pleased to announce that we have received an EU Quality Management System Certificate under Regulation (EU) 2017/746 (IVDR). This certificate covers our Newbio TPHA and Newbio RPR product ranges (class C devices).
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