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Regulatory Challenges of SaMD: Navigating Global Standards and Compliance

Posted by: Rohit Pal November 4, 2024

Overview Navigating Software as a Medica

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4th November, 2024

The Future of SaMD: Emerging Trends and Innovations

Posted by: Rohit Pal November 4, 2024

Overview The future of (SaMD) Software a

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4th November, 2024

Understanding SaMD: What Makes Software a Medical Device?

Posted by: Rohit Pal November 4, 2024

Overview Software as a Medical Device re

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4th November, 2024

Quality Management Systems for SaMD: Best Practices and Standards

Posted by: Rohit Pal October 22, 2024

Overview Quality Management Systems for

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22nd October, 2024

Clinical Validation of SaMD: What You Need to Know

Posted by: Rohit Pal October 22, 2024

Overview Clinical validation of Software

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22nd October, 2024

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Regulation/Guidelines

Regulatory Challenges of SaMD: Navigating Global Standards and Compliance

Overview Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications. Challenges include managing risks, demonstrating clinical evidence, and ensuring data security. Harmonisation efforts and...

4th November, 2024

Regulation/Guidelines

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...