Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
Have you heard this term before? While it seems like a nebulous part of the innovation process, it actually has some structure, and can be done around design stages and activities that help teams flesh out product concepts and begin to innovate.
February was sort of a quiet month for FDA, but here are some updates worth checking out! Request for Comment: Medical Device Labeling Regulations FDA has put out a request for public comment on existing medical device labeling regulations. While this may be a response to recent calls from manufacturers worried about increasing regulatory burdens, it seems aligned with FDA’s continued drive to decrease regulatory burdens on life science organizations.
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What technologies will shape product development and life science innovation in 2018? We’ve highlighted four of the biggest tech disruptors to life science industries and why they’re so critical to innovation in the coming year.
In the “Classify Your Medical Device” blog series, we look at each classification and what is required for your device to move from development to commercialization. By now, you’re familiar with the basics of FDA’s medical device classification system. The system’s classes (Class I, Class II, Class III) all relate to how much risk is posed to patients and/or users, along with device effectiveness and reliability plus the intended use. So, what is the threshold of these factors that make a device Class II instead of Class I?
So-called “innovation insights” are a dime a dozen in life science industries today. How can you distinguish which are fact versus myth?
Welcome to the new regulatory year! Here are some FDA updates worth following this month:
How are medical devices classified by FDA? What does classification mean for your product?
With FDA’s clearance of AliveCor’s KardiaBand EKG reader, the Apple Watch now has its first medical device accessory. This is a big deal in the medical device industry, but why?
Do you know if your medical device is classified as Class II Special Controls? Does your submission provide “reasonable assurance(s) of safety” to FDA? Knowing the answers to these questions ahead of time saves you time, energy, and hassle. If you’re unsure, search FDA’s device classification page for your device type; if it’s classified as Class II Special Controls, you may need to satisfy these three controls: