Quality Assurance is essential to the success and future endeavours of Newmarket Biomedical. We hold certification for ISO 13485 and MDSAP from the British Standards Institute (BSI) and we are compliant with Directive 98/87/EC and Regulation (EU) 2017/746 for in vitro diagnostic medical devices.
Further improvements to the Quality Management System (QMS) are continually being undertaken throughout the company and are implemented enthusiastically by all staff members.
Our Quality Policy underlines our desire for high quality products and service, our dedication to the necessary regulatory requirements and our commitment to the growth and support of our staff.
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).
We will be transitioning to supply IVDR labelled products to our distributors and customers over the coming months so please look out for these exciting changes.
PK-TPHA product for use on PK7300 will not be certified under the IVDR. However, an updated product will be available as Class D certified for use on the PK7400 analyser through Beckman Coulter, this Certification is ongoing.
SYPHILIS EIA Total Antibody, there are no plans to certify this product under the IVDR. This product is only available on special request and a minimum order quantity will apply.
Adobe PDF [233.70 kb]
Adobe PDF [397.94 kb]
Adobe PDF [455.81 kb]
Adobe PDF [413.37 kb]
If you require an IVDD Instruction for use, please contact us at info@new-bio.com.
Adobe PDF [237.31 kb]
Adobe PDF [280.80 kb]
Adobe PDF [361.84 kb]
Adobe PDF [267.14 kb]
Adobe PDF [388.53 kb]
Adobe PDF [232.84 kb]
Adobe PDF [232.96 kb]
Adobe PDF [237.60 kb]
Adobe PDF [238.53 kb]
Adobe PDF [210.98 kb]
Adobe PDF [240.65 kb]
Adobe PDF [170.55 kb]
Adobe PDF [664.57 kb]
Adobe PDF [679.02 kb]
Adobe PDF [243.17 kb]
Adobe PDF [648.38 kb]
Adobe PDF [639.99 kb]
Adobe PDF [646.31 kb]