European Commission approva Archives - CliniExperts -CliniExperts

European Commission approva

Pfizer, Bristol get EU nod for blood clot preventer

Posted by: admin November 21, 2012

(Reuters) – European health regulators on Tuesda

European Commission approva

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21st November, 2012

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Regulation/Guidelines

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The Future of SaMD: Emerging Trends and Innovations

Overview The future of (SaMD) Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring. Emerging trends emphasise real-time data integration, stronger regulatory...

4th November, 2024

Regulation/Guidelines

Understanding SaMD: What Makes Software a Medical Device?

Overview Software as a Medical Device refers to software applications designed for medical purposes, such as diagnosis, treatment, or monitoring, without being part of a physical device. Software as a...

4th November, 2024

Regulation/Guidelines

Quality Management Systems for SaMD: Best Practices and Standards

Overview Quality Management Systems for SaMD requires compliance with regulatory standards, implementation of robust quality management systems, and risk management through design controls, testing, and post-market surveillance. It also involves...