Articles
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Apr 6, 2024 |
meddeviceonline.com | Edwin L. Bills |Christie Johnson |Jayet Moon |Renee Bailey
On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.
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Mar 12, 2024 |
meddeviceonline.com | Edwin L. Bills |Christie Johnson |Jayet Moon |Michael Moussourakis
On February 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by February 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.
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Feb 29, 2024 |
meddeviceonline.com | Edwin L. Bills |Christie Johnson |Jayet Moon
By Edwin Bills, Christie Johnson, and Jayet Moon On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. This regulation marks a pivotal transition from the guidelines previously stated in 21 CFR 820.5, forging a pathway toward an integrated approach that aligns with global standards.
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Dec 18, 2023 |
meddeviceonline.com | Edwin L. Bills |Christie Johnson |Eric Hinrichs |John Giantsidis
Measuring CleanlinessTOP PRODUCTS AND SERVICESConnect With Med Device Online:
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Nov 22, 2023 |
unsustainablemagazine.com | Christie Johnson
By Christie JohnsonVUCA: Volatile, Uncertain, Complex, Ambiguous. This is the world we live in. From the COVID-19 pandemic and the explosion of generative AI to the Israel-Palestian conflict and a fast-moving climate crisis. Humanity is undoubtedly facing huge and unprecedented extremities. On the face of it all, our day-to-day lives appear to move in the same methodical and uninterrupted way. But the systems we navigate within – natural and manmade – are deteriorating.
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