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.
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?
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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.
Over one-third of all Class II devices now have “Special Controls” designations from FDA. The rate of such classifications in the last seven years has increased by over 240 percent (Desjardins 2010). What is driving this trend?
Why should you care about completing human factors engineering (HFE) in relation to your supply chain? Simple: humans are involved. At every stage of your medical device’s lifecycle, there are people participating in assembly, handling, packing, and so on. Particularly during manufacturing, your team wants to focus on HFE exercises to help control risks that could arise in later lifecycle stages. But what manufacturing steps should be evaluated with human factors in mind?