Medical Device & IVD Regulatory | SCIENCE ARENA

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Significance of Clinical Evidence in the Medical Landscape

bySCIENCE ARENA -December 06, 2023

Clinical evidence stands as the cornerstone in the rigorous evaluation of medical devices, provi…

What Should Be Submitted under Clinical Evidence - Requirements Related to Medical Device Rules & Regulation (CDSCO, EU, US FDA)

bySCIENCE ARENA -January 27, 2024

The convergence of requirements for clinical evidence is expected to yield several significant b…

Navigating the Regulatory Landscape of Software as a Medical Device (SaMD) Compliance Challenges, Best Practices, and Future Trends - White Paper

bySCIENCE ARENA -April 25, 2024

1. Introduction In today's rapidly evolving landscape of digital healthcare, we a…

Essential Principles of Safety and Performance for 💉 Medical Devices: Key Considerations and Compliance

bySCIENCE ARENA -July 02, 2024

The Essential Principles of Safety and Performance for medical devices are designed to ensure t…

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