Regulatory, Quality and Compliance

At Lenus Health, we prioritise the safety and well-being of patients and healthcare professionals by providing high-quality medical device software.

We understand the critical role that regulatory compliance plays in the healthcare industry. That's why we adhere to strict standards to ensure our Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD) products meet the highest quality and safety benchmarks.

Here's how we ensure regulatory and compliance excellence:

• We develop products in line with our extensive Standard Operating Procedures (SOPs) which underpin our Quality Management System (QMS) which is certified to BS EN ISO 13485:2016
• We comply with the requirements of the European Union Medical Device Regulation (EU MDR) with medical software devices conforming to Class I, CE marked.
• We comply with the requirements of the United Kingdom Medical Device Regulation (UK MDR) with medical software devices conforming to Class I, UKCA marked.
• We comply with the Digital Technology Assessment Criteria for health and social care (DTAC) for use in NHS England.
• We comply with the Data Security and Protection Toolkit (DSPT) for use in NHS England.
• Our medical software devices registered with the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
• We are Cyber Essentials and Cyber Essentials Plus certified, the United Kingdom cyber security certification scheme promoted by the National Cyber Security Centre.

ISO 13485 Quality Management System

Lenus Health maintains an ISO 13485 certified Quality Management System (QMS). This internationally recognised standard, specifically designed for medical device manufacturers, focuses on quality, safety, and regulatory compliance throughout the product development lifecycle.

MHRA Registration

Our medical software devices are registered with the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory authority for medical devices in the United Kingdom.

UKCA and CE Marking

Lenus Health's medical software devices bear the UKCA (UK Conformity Assessed) and CE marks, which are essential for marketing and selling our medical device software in Great Britain and the European Economic Area (EEA).

Our medical device software is developed in accordance with ISO 13485 and ISO 27001 for quality and security. It is registered and certified with regulatory bodies including the Medicines and Healthcare products Regulatory Agency (MHRA) and the NHS.

• ISO 13485
• ISO 27001
• UKCA Class I and working towards UKCA Class lIb
• CE Class I
• Cyber Essentials
• Cyber Essentials Plus
• DTAC (Digital Technology Assessment Criteria)
• DSPT (Data Security and Protection Toolkit)