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.
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?
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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:
Earlier this month, we sent two members of our Cockpit Crew down to Virginia for training on Standard Operating Procedures. As part of Cognition’s ongoing effort to educate ourselves and expand the scope of our product offerings, we decided it would be worthwhile to get more training in technical writing.
Our Thought Leadership series, “FDA Pulse Check,” attempts to highlight and break down the latest news, updates, and initiatives from FDA relevant to medical device, pharmaceutical, and combination product industries.
We are excited to announce the appointment of David Taylor to the CTO position at Cognition Corporation. Mr. Taylor has been with Cognition for over 19 years. During that time, he has held positions as Cockpit Development Lead, Lead Cockpit Architect, and most recently, Vice President of Software Development.