UKCA Declaration of Conformity

Manufacturer

Endeavour Predict Limited declares that under our sole responsibility, the product:

EP Predict Engine

is in conformity with all relevant Articles, Annexes, Essential Requirements, and provisions of the following UK Regulations, including all amendments and national legislation implementing these Regulations:

UK Medical Devices Regulations (2002)

Classification

Class 1 - Active Medical Device – Clinical management support software
(GMDN Code 61087)

Standards and technical specifications applied

• BS EN ISO 13485:2016+A11:2021
• BS EN 62304:2006 + A1:2015
• BS EN ISO 14971:2019+A11:2021
• BS EN ISO 15233-1:2021
• DCB0129:2018