SaMD (Software as a Medical Device)

As a Software as a Medical Device (SaMD) developer and QMS provider, Yoctobe supports NHS Trusts in achieving DTAC compliance by providing compliant software development and ISO-ready eQMS infrastructure. This guide outlines Yoctobe’s role in supporting NHS Trust DTAC compliance…

1. Overview Yoctobe Ltd. is a UK-based health technology company specialising in Software as a Medical Device (SaMD) engineering and Quality Management System (QMS) enablement.Yoctobe develops compliant medical-grade software, provides an ISO-ready electronic Quality Management System (eQMS), and supports its…

The integration of digital technologies into healthcare systems represents both tremendous opportunity and significant challenges. To address these challenges, NHS England established the Digital Technology Assessment Criteria (DTAC) framework—a comprehensive approach to evaluating digital health technologies seeking adoption within NHS…

Post-market surveillance (PMS) represents a critical phase in the lifecycle of medical devices, including Software as a Medical Device (SaMD). This systematic process of monitoring device performance after market placement helps ensure ongoing safety and effectiveness while facilitating continuous improvement.…

MHRA Registration The Medicines and Healthcare products Regulatory Agency (MHRA) registration is a mandatory requirement for placing medical devices, including Software as a Medical Device (SaMD), on the UK market. This registration process serves as a crucial regulatory checkpoint that…

Clinical evaluations and investigations form critical components of the medical device regulatory pathway, particularly for Software as a Medical Device (SaMD). This document provides a comprehensive overview of these processes within the UK regulatory framework. Clinical Evaluations A clinical evaluation…