by Chad Brueck | Sep 30, 2024 | MDC Blog
by Matthew Faron, PhD September marked Sepsis Awareness Month and to support this important cause we are revisiting our previous post on rapid Antimicrobial Susceptibility Testing (rAST) from positive blood culture bottles (PBC). In that post, we discussed innovative...
by Chad Brueck | Sep 12, 2024 | MDC Blog
by Matthew Faron, PhD After the ADLM conference in Chicago in July, it was amazing to reflect on the extent of innovations occurring in the IVD market and the laboratory community. The sheer scale of the conference was overwhelming with over 18,000 laboratory...
by Chad Brueck | Sep 9, 2024 | MDC Blog
Traditionally, when manufacturers needed to make significant modifications to a 510(k) or PMA, they had to submit either a Special 510(k) or a completely new premarket notification to the FDA. However, in response to the evolving medical device landscape, a new option...
by Chad Brueck | Aug 9, 2024 | MDC Blog
by Audrey Skeen Regulation: MDUFA V Issuing Authority: Food and Drug Administration (FDA) Effective Date: October 1, 2024 – September 30, 2025 Updated FY 2025 User Fees The FDA has announced the updated FY 2025 (October 1, 2024, through September 30, 2025) User...
by Chad Brueck | Jul 31, 2024 | MDC Blog
by Matthew Faron, PhD Sepsis is one of the leading causes of death in hospitals, contributing to 49 million cases worldwide in 2017 (Rudd 2020). Timely diagnosis and treatment with appropriate antibiotics are crucial for patient survival. Until recently, laboratories...
by Chad Brueck | May 24, 2024 | MDC Blog
Fostering a quality culture goes deeper than just following a set of rules. In the med tech industry, you need a total shift in your mindset and function. This change begins at the top and moves through every level of an organization. At the 2024 Med Tech True Quality...
