Edwin L. Bills

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04.06.24 -- March's Most Popular Articles & Solutions

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.
03.12.24 -- New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis

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.
New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis

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.
12.18.23 -- Top 10 Of 2023

Dec 18, 2023 | meddeviceonline.com | Edwin L. Bills |Christie Johnson |Eric Hinrichs |John Giantsidis

Measuring CleanlinessTOP PRODUCTS AND SERVICESConnect With Med Device Online:
What Can The Medical Device Industry Learn From The Boeing 737 MAX 8 Crashes?

Mar 21, 2023 | meddeviceonline.com | Edwin L. Bills

By Edwin L. Bills, Consultant for Qosina Boeing has been in the news frequently for two crashes involving the 737 MAX 8 aircraft. One commonality between the 737 MAX 8 aircraft and medical devices is that the company marketing the device is responsible for everything in it, regardless of who created the product. Risk management is a crucial part of any design and development process.
The Clock Is Ticking: Will Notified Body Capacity For The EU MDR Affect You?

Mar 21, 2023 | meddeviceonline.com | Edwin L. Bills

By Edwin L. Bills, Consultant for Qosina Explore the progress of the new European Union Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) and how the lack of Notified Bodies (NB) could affect timely implementation. The deadline is looming larger and some small progress has been made, along with some steps backward. This paper has been updated to reflect recent developments and to bring the current situation into focus.