This article -- the second in a two-part series -- examines how to navigate the complex problem of optimizing data quality while controlling for study costs and time constraints when employing independent HFE testing agencies.
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’s Software Precertification (Pre-Cert) Pilot Program aims to move away from the traditional 510(k) and De Novo pathways, and to develop a program better suited for technologies that have a rapid development and update lifecycle.
For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”
In medical device design and development, two critical development activities — device evaluation and device design verification — often are treated as one, and this behavior is shockingly detrimental to successful medical device development.
During a recent meeting of data integrity professionals, a fundamental question was posed by a member of the group: “How can one prevent or detect malicious intent as it relates to changes to information and the impact to data integrity?”
Well-designed training maximizes learner retention and understanding, and focuses on the information needed for safe and successful use. It also is important to understand that training for purposes of risk management cannot prop up a poorly designed device.