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Regulatory Updates on Disinfectants

Posted by: admin August 11, 2021

Sanitizers can be of different variants, prim

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11th August, 2021

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Regulation/Guidelines

Clinical Investigation Approvals: An Overview of Forms MD-22 and MD-23

Summary As per MDR, 2017, “clinical investigation” means the systematic study of an investigational medical device in or on human. participants to assess its safety, performance or effectiveness Clinical investigation...

15th January, 2025

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

Alcohol based hand sanitizers

Alcohol based hand sanitizers

Regulatory Updates on Disinfectants

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