This article provides a high-level review of some existing prostate cancer diagnostic assays used for screening, risk stratification, and monitoring treatment response. It also discusses opportunities for development in prostate cancer diagnostics.
Although sample sizes for medical device usability testing are mostly defined by regulatory standards, it is important for manufacturers to understand the underlying principles, and to make sound decisions accordingly.
Medical device prototypes at each development stage have a utility that needs to be understood to justify the cost and time invested to develop them.
The United Kingdom’s plan to leave the European Union has devolved into a mess of shifting deadlines and what-ifs. Here, Zaid Al-Nassir breakdown for medtech leaders has been updated to include events taking place through April 11, 2019.
In October, the U.S. FDA published an updated draft of Premarket Cybersecurity Guidance and introduced the concept of a cybersecurity bill of materials (CBOM) for medical devices. Some medical device manufacturers have since raised concerns regarding mandating CBOMs in the 510(k) or premarket approval packet.
The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.
Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?
With input from FDA and regulators, CQOs are pursuing means to analyze huge data sets, manage complex manufacturing systems, and operate smoothly between varied products, languages, and cultures.
NESTcc was envisioned as a cooperative network of partners working to use data, advanced methodologies, and good governance to improve the state of medical device evidence generation. Find out what’s yet to come, and how you can weigh in.
While the new version of The Least Burdensome Provisions guidance does not institute sweeping reforms, it does offer new methods for medical device manufacturers to expedite the premarket review process for product approvals, as well as clarifies how both the FDA and industry can implement the least burdensome principles in practice.
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