While regulations are in place to help minimize EMI, some amounts are unavoidable, and larger amounts can be generated in rare circumstances, or in the event of device malfunction. Thus, preventative measures, including EMI shielding and filtering, must be employed to protect both implantable medical devices and their host patients.
The guidance looks at what constitutes a manufacturing site change, when a manufacturer should submit a PMA supplement, what documentation should be submitted to the FDA with a site change supplement, and more.
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.
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.
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