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EU AI Act & ISO 42001 – Cybersecurity and Governance for AI-Driven Medical Devices
The EU AI Act Will Reshape How You Build, Certify and Maintain Software as a Medical Device The EU Artificial Intelligence Act is the...
NIS2 & Executive Liability – A Critical Priority for Medical Device Manufacturers
NIS2 Is Here. Are You Ready to Be Held Personally Accountable? The NIS2 Directive, in force across the EU from October 2024, introduces...
Digital Technology Assessment Criteria (DTAC)
It is essential that any digital health technologies undergo proper assessment. This ensures they meet quality standards and are safe for...
DCB0160 Clinical Risk Compliance Services
DCB 0160 is the counterpart standard to DCB 0129 . Whereas the former applies to manufacturers of technology, DCB 0160 applies to public...
Data Security and Protection Toolkit Support
Learn more about how we can fully project manage and optimise your annual mandatory NHS Data Security and Protection (Toolkit) returns...
Clinical Safety Officer (CSO)
The Clinical Safety Officer (CSO) is one of the cornerstones of NHS clinical safety compliance . Filling this role is one of the most...
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