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Sep 12, 2024 | 
biosimilardevelopment.com | Jayet Moon |Arun Mathew |Mike Ulman |Anupreet Kaur
Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations. The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.
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Aug 30, 2024 | 
outsourcedpharma.com | Jayet Moon |Arun Mathew |Louis Garguilo |David Lyon
The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024. In Defense Of The Full-Time Equivalent (FTE)"Back in the day," says Chief Editor Louis Garguilo, "it proved most optimal for my biopharma clients ... I’m speaking of the full-time equivalent (FTE) model at CDMOs for your drug development (and certain manufacturing) needs.
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Aug 14, 2024 | 
meddeviceonline.com | Jayet Moon |Arun Mathew
By Jayet Moon and Arun Mathew
The FDA released a new draft guidance, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products, in early July. It provides guidance to industry and FDA staff on the purpose and content of a risk management tool for usability, a use-related risk analysis (URRA), that has recently gained lot of currency with the FDA.
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Jul 9, 2024 | 
meddeviceonline.com | Jayet Moon |Arun Mathew |Jessica Sanford |Jeff Phillips
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| July 9, 2024
The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (QMSR), risk management can be integrated with the design control process. RFID For Med Devices: Identifying A PartnerRFID is increasingly being used in medical devices.
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Jun 6, 2024 | 
meddeviceonline.com | Jayet Moon |Arun Mathew
By Jayet Moon and Arun Mathew
In the highly regulated field of medical device development, ensuring product safety and efficacy while maintaining compliance with regulatory standards is paramount. Central to this is the design process that is founded on design controls, which provides a systematic framework for translating user needs into tangible product features while effectively managing risks.
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Apr 22, 2024 | 
meddeviceonline.com | Jayet Moon |Arun Mathew
By Jayet Moon and Arun Mathew
In the realm of medical device development and manufacturing, adherence to stringent regulatory standards is not just a legal requirement, it’s also a fundamental aspect of ensuring product safety and efficacy. For years, the FDA's design controls under 21 CFR Part 820 (Quality Systems Regulation [QSR]) have served as a cornerstone for guiding manufacturers through the process of designing and design transfer of medical devices.
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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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May 10, 2023 | 
meddeviceonline.com | Jayet Moon
By Jayet Moon, author of the book Foundations of Quality Risk Management
In the context of ISO 14971:20191 and risk management for medical devices, manufacturers and designers are often confused about the implementation of hazard analyses and FMEAs (failure modes and effects analyses), especially since this standard takes a hazard-based approach.
