An experienced Clinical Safety Officer is essential for compliance with DCB0129 and DCB0160 and is mandated by the Health and Care Act (2012). Let us be your guide.
When introducing healthcare solutions into the NHS, DCB0129 & DCB0160 Clinical Safety Standards should form an integral part of the development and implementation of technology.
The CSO role focuses on ensuring a ‘clinical lens’ is applied to product risk management, aiding manufacturers to make informed design decisions, supporting compliance with ISO 14971 for Medical Device Manufacturers and aiding the NHS to deploy technology safely.
A named Clinical Safety Officer (CSO) is also essential for compliance with the NHS Digital Technology Assessment Criteria (DTAC) alongside compliant documentation according to DCB0129
A Clinical Safety Officer is a registered healthcare professional, appointed by your organisation, to manage clinical risk according to DCB0129 or DCB0160 for Healthcare IT.
Their role involves working with multiple teams including Engineering, Product, Regulatory and Implementation to ensure that products are developed and deployed in a safe and compliant way
The CSO plays a pivotal role across various aspects of your organisations, with senior management ultimately bearing the responsibility for decisions and outputs concerning potential hazards or clinical incidents.
They act in your business’s best interests to ensure technology development and deployment follows a key principle of the Hippocratic Oath: “First, do no harm”. Their experience in clinical settings and risk management programmes prove them to be an asset to organisations not only looking to comply with DCB0129/DCB0160 but also across the organisation.
We understand that every health tech business is unique and that the risk profile of each product can vary. That’s why, our experienced team of UK-registered Clinical Safety Officers, will work alongside you to:
Our guidance and support doesn’t just stop with documentation management.
Our CSOs work as part of a multi-disciplinary team of clinical risk management professionals, regulatory specialists and subject matter experts, enabling them to bring a breadth and depth of experience to the process of DCB0129/DCB0160 management, incomparable to the rest of the market
Book a free, no-obligation discovery call with our experienced team to see how we can help fulfil the role of the CSO and support DTAC compliance.
This enables us to pass on best practice to your organisation and support safe development.
We understand how clinical safety standards can be embedded in existing Regulatory frameworks. Benefit from our breadth and depth of knowledge to support embedding the CSO within your business.
We consider it our personal mission to ensure that transformative health technologies reach everyone who needs them.
This enables us to pass on best practice to your organisation and support safe development.
We understand how clinical safety standards can be embedded in existing Regulatory frameworks. Benefit from our breadth and depth of knowledge to support embedding the CSO within your business.
We consider it our personal mission to ensure that transformative health technologies reach everyone who needs them.
Our expert team can handle everything, from creation of core documents to implementing a Clinical Risk Management System – we’ll help you find a route from where you are, to where you need to be.
A Clinical Safety Officer is a registered healthcare professional, appointed by your organisation, to manage clinical risk according to DCB0129 or DCB0160 for Healthcare IT.
The Clinical Safety Officer (CSO) plays a pivotal role across various aspects of your organisations, with senior management ultimately bearing the responsibility for decisions and outputs concerning potential hazards or clinical incidents. They act in your businesses best interests to ensure technology development and deployment follows a key principle of the Hippocratic Oath; "First, do no harm". Their experience in clinical settings and risk management programmes prove them to be an asset to organisations not only looking to comply with DCB0129/DCB0160 but also across the organisation.
A clinical safety officer must be a registered clinician, such as a doctor, nurse, or pharmacist, with appropriate training in clinical risk management. They should be familiar with the clinical domain of your product.
The Clinical Risk Management System should be reviewed regularly, with the frequency of reviews depending on the complexity of the product, the nature of the clinical risks identified, and any changes in clinical practice or technology. At a minimum, an annual review is recommended.
An experienced Clinical Safety Officer is essential for compliance with DCB0129 and DCB0160, mandated by the Health and Care Act (2012).
Meeting DCB0129 or DCB0160 can seem daunting and complex, but it doesn’t have to be. Access our free Blogs to learn more about these important Clinical Risk Management Standards for Digital Health, MedTech and Medical Service Providers.
Let’s see how we can help you navigate DCB0129 and Clinical Risk Management.
