Why Choose DPM Digital Health’s Clinical Risk Management Course?

When it comes to Clinical Risk Management (CRM) training, choosing the right course is crucial. At DPM Digital Health, we go beyond just ticking the compliance box—we ensure you leave with the confidence and practical skills needed to implement CRM effectively in real-world digital health environments. Over the years, we’ve seen many digital health teams […]

An amazing 2024, here’s to 2025!

We are already a week into 2025 following a roller coaster of a year in 2024! I didn’t put anything out at the end of December as I have been battling with my Colitis and had a hernia repair thrown in for good measure. Thankfully, I am making a speedy recovery. A big thank you […]

What is the worth of a CSO?

What is the worth of a CSO?

Co-authored by Dean Mawson, Clinical Director / Founder, DPM Digital Healthm, and Tom Bradshaw, Clinical Safety Officer & GP and Founder of BMS Digital Safety. Buying budget – not always buying best. Ever regretted buying that knock-off detergent that left you with a nagging itch? Sometimes cost cutting isn’t worth it. The same goes for […]

Why Digital Health Manufacturers in the UK Should Adopt ISO 13485 Over ISO 9001

Why Digital Health Manufacturers in the UK Should Adopt ISO 13485 Over ISO 9001

“Digital health manufacturers face unprecedented challenges – regulatory landscapes are tightening, patient safety demands are escalating, and innovation is accelerating. Choosing the right Quality Management System (QMS) standard isn’t just about compliance; it’s about staying competitive in a fast-evolving market. At DPM Digital Health, we believe ISO 13485 is the foundation for ensuring quality, safety, […]

Medical Device Regulation and harmonised standards

Medical Device Regulation and harmonised standards

The regulatory standards and guidance documents below are crucial for ensuring the safety, quality, and efficacy of medical devices in healthcare settings.  Here’s a detailed summary of each, along with their harmonisation for medical device regulatory compliance: EU MDR 2017 (European Union Medical Device Regulation) The EU MDR 2017 is a comprehensive regulation that governs […]

AI regulatory standards and risk management guidance

AI regulatory standards and risk management guidance

IEC BS 42001 IEC BS 42001 is a standard for Artificial Intelligence Management Systems (AIMS). It provides a framework for organizations to manage AI systems effectively and responsibly. In healthcare, IEC BS 42001 can be applied to: IEC BS 30440 IEC BS 30440 focuses on the ethical considerations in AI system design and development. For […]

Artificial Intelligence in Healthcare

ai in healthcare

Artificial Intelligence (AI) is a broad field of computer science focused on creating systems that can perform tasks that typically require human intelligence. Here’s an overview of key AI concepts and their application in healthcare: Definition of AI AI refers to the simulation of human intelligence in machines programmed to think and learn like humans. […]

Clinical Risk Management Governance

Clinical Risk Management Governance

Overview Clinical Risk Management (CRM) governance is crucial in the development, deployment, and use of digital health technologies within the UK healthcare sector. It ensures that these technologies are safe, effective, and aligned with clinical needs, thereby safeguarding patient health and enhancing care delivery. Importance of CRM Governance Purpose of CRM Governance Integrating CRM Governance […]

Clinical Risk Management File

Clinical Risk Management File

A clinical risk management file in relation to DCB0129 and DCB0160 NHS safety standards is a comprehensive document that outlines the approach to identifying, assessing, and mitigating clinical risks associated with Digital Health Technologies. It not only provides the safety documentation as required by the NHS Safety Standards but acts as a repository for all […]

What is DCB0129?

What is DCB0160

DCB0129, otherwise known as “Clinical Risk Management: its Application in the Manufacture of Health IT Systems”, is a standard that provides a framework for Digital Health manufacturers to ensure the clinical risk management of their products. It was made mandatory under the Health and Social Care Act 2012 for any organisation responsible for the development […]