Tying PMS and PMCF Requirements Back to Risk Management
Medical device manufacturers’ obligation to meet regulatory requirements continues throughout the medical device lifecycle, including the post-production phase (post-market). Medical device manufacturers must implement an effective post-market surveillance system per the various applicable regulations.
Who Needs a Q-Sub, and When?
So many questions come up when developing a medical device. What is its intended purpose? Who will use it? How will it be used? What do we need to do? Questions surrounding the medical device regulations and the paperwork involved can be intimidating. Setting up a Q-Submission meeting with the FDA can help if you […]
How Quickly Can You Rapid Prototype a Medical Device?
Designing, developing, and getting a medical device on the market involves risk. It requires a large investment of your company time, resources, and reputation. It also includes risk for the health and safety of your customers and patients. One way to reduce those risks is through using medical device prototyping. While device prototyping offers much […]
Applying human factors and usability engineering to medical devices
Human factors (HF) and usability engineering (UE), or as some call it, medical ergonomics, is the process of evaluating and changing the design of a device to better fit the human body and its cognitive abilities. The FDA defines it as “the application of knowledge about human behavior, abilities, limitations, and other characteristics of medical […]
Three Takeaways from the Human Factors Engineering & Usability Studies Congress
In early December, I had the good fortune of attending the Human Factors Engineering & Usability Studies Congress online. Although the event could not be held in person, for obvious reasons, it yielded numerous insights critical to the field of human factors engineering. With a deep-dive into the latest thinking and trends, the two-day event […]