The topics covered in this article represent some of the common risk management pain points and mechanisms to overcome these challenges, focusing on the foundation of quality risk management (QRM). This includes using consistent terminology, determining risk strategy, implementing QRM, and the advantages of early implementation.
The expanding use of extended reality (XR) in medical applications presents a number of unique opportunities and challenges. Due to the extensive reliance on software and networked data, cybersecurity risks must be addressed during the design, development, and use of XR devices. And, of course, compliance with all regulations concerning privacy and control of PII is essential.
Say “start-up” in the medical device community and the conversation can move quickly to funding. Who will invest? How much? How long will it take? Here are five tips to help a medical device start-up be more interesting, more attractive, more investable – and less risky – to potential funders.
While face-to-face access is once again possible, and access continues to improve, it has not, and will not, return to 100% of pre-pandemic levels. Medical device organizations must evolve their commercial strategies to be more flexible, resilient, and nimble. Hierarchical decision-making and slow time-to-market strategies should be replaced by operational agility as well as a “test-and-learn” culture that demands cross-collaboration and values data-driven solutions.
ISO Standards: Turning Hopes Into True Quality Objectives
Aligning your company’s quality management practices with the applicable quality principles found in the ISO 9000 family of standards is a proven approach for turning aspirations into actual quality objectives. Here, we review key quality principles addressed in ISO 9001 and examples of ways the standard can be leveraged to reach the kinds of objectives your organization may be looking to achieve.
Process mapping and gap analysis can help manufacturers not only show the FDA that an organization is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.
Commercial off-the-shelf (COTS) software has dramatically enhanced medical device manufacturers’ ability to accelerate production, integrate processes, and manage quality effectively. Learn more about FDA guidelines on the horizon for COTS software and tips on how to approach validation until such guidelines are finalized.
We need to remedy the fact that the vast majority of life science manufacturers are still on paper. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.
There are three key differences between sub-6 GHz and mmWave operations. There are also a variety of different RF design challenges at mmWave largely because as frequency increases, wavelength decreases.
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Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.More Content Collections