Regulatory
Paige’s portfolio of products are all designed, developed, thoroughly tested, deployed, and then continually maintained with adherence to the highest regulatory standards. Quality and safety is our top priority.
CE-IVD Marked
Conformite Europeenne – in vitro diagnostic medical device (IVDD) and in vitro diagnostic regulations (IVDR)
Paige has obtained 13 CE marks (under IVDD regulation) for 18 of its products in European Union since 2020 up until the date of application for In Vitro Diagnostic Regulation (IVDR).
Our flagship product, FullFocus®, has achieved the IVDR CE Mark, showcasing our dedication to safety, performance, and quality. This accomplishment underscores Paige’s commitment to upholding the highest levels of regulatory compliance and ensuring the delivery of safe and effective solutions to the market. Paige is currently in the process of transitioning its other products to be CE marked under IVDR.
FDA-Approved
United States Food and Drug Administration
FullFocus™ Whole Slide Image Viewer has been cleared by the FDA for sale in the United States as of July 2020.
FullFocus™ FDA Decision Summary (K201005)
Paige Prostate Detect has received de novo marketing authorization from the FDA for sale in the United States as of September 2021.
ISO 13485:2016 Certified
Quality Management for Medical Devices
Paige has been certified by the British Standard Institute (BSI) in Quality Management for Medical Devices which recognizes the design and development, manufacture, installation, and servicing of in-vitro diagnostic software, used in the detection and diagnosis of cancer from digitized pathology images.
MDSAP Certified
Medical Device Single Audit Program
Paige has been MDSAP certified by the British Standard Institute (BSI) for the design and development, manufacture, installation, and servicing of in-vitro diagnostic software, used in the detection and diagnosis of cancer from digitized pathology images.
UKCA Marked
UK Conformity Assessed
Under the Medicines and Healthcare products Regulatory Agency (MHRA) regulation Paige has received 13 UKCA marks under Part IV of UK MDR, for 18 of its products in United Kingdom since 2022.
Registration of these devices are available on the MHRA Registration Database
