Unsure about medical device labelling?
Accurate labelling of medical devices is vital for the safe and proper use of medical devices by patients and care givers and is a key thing to get right when bringing a product to market. ISO 13485 considers medical device labelling includes the label, instructions for use, and any other information that is related to […]
Digital clinical safety risks and AI
The advent of artificial intelligence (AI) in healthcare promises to revolutionise patient care pathways, offering unprecedented advances in digital clinical support and decision-making systems. AI-driven systems have the potential to significantly improve condition severity assessments, treatment pathways, and diagnosis accuracy. However, their integration into healthcare settings introduces a new class of clinical risks that necessitate […]
Implementing ISO 42001 for Ethical and Efficient AI Management
Implementing ISO 42001 for Ethical and Efficient AI Management is crucial for organizations striving to maintain high standards of ethical practices and operational efficiency in artificial intelligence. This comprehensive guide delves into the key principles of ISO 42001, providing insights into ethical AI governance, compliance strategies, and best practices for AI implementation. By adhering to these standards, organizations can ensure responsible AI development and deployment, fostering trust and reliability in AI systems.
Partnering for Success: Deviceology and Anthropos Journey to Ensuring Quality and Safety
Introduction In the fast-evolving landscape of digital health, the need for credible regulatory partners has never been more crucial. Deviceology Ltd (“Deviceology”) is proud to share our recent collaboration with Anthropos Digital Care Ltd (“Anthropos”) to implement an ISO 13485 Quality Management System (QMS) and develop a Medical Device Product Technical File compliant with the […]
AI and the Evolution of Clinical Risk Safety Standards
AI-driven systems have the potential to significantly improve patient assessments, treatment pathways, and diagnosis accuracy. However, their integration into healthcare settings requires a new focus for clinical digital risks necessitating careful consideration and a new thinking to address the challenges…
Navigating the Future of Medical Devices in the EU Health Data Space
1. Introduction The European Union is at an important juncture in healthcare innovation, driven by the European Health Data Space (EHDS). This initiative aims to standardise and digitalise health data across EU member states, thereby fostering innovation in medical devices and treatments. However, the implementation of this data space presents challenges, particularly in regulatory compliance […]