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.
NAVIGATE2019, Cognition’s annual user conference, has officially wrapped up. We heard many great talks, panels, and discussions over the course of the two-day event. Here’s a brief overview of the conference—what we discussed, what we learned, and how that information will impact Cognition moving forward.
It’s been quite a summer for FDA. Between a number of recalls, product approvals, releases of consumer information, and updates to key agency programs, there’s a lot to catch up on. Here are a few of the highlights we think are worth keeping an eye on.
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Drug stability reporting has been a major area of interest for Cognition as of late. To get a better understanding the current environment, we coordinated our Summer Internship Program around this topic. Led by our interns Olivia O'Brien and Brigitte Cronin, this effort has yielded a vast amount of important and intriguing insights about the current state of drug stability reporting in pharmaceutical industries. Here are a few of those insights and what they can tell us about this vital aspect of pharmaceutical compliance.
The new European Medical Device Regulation (EU MDR) is on its way. Soon, medical device manufacturers wishing to submit to European markets will need to comply with a set of new and critically important regulations. However, even with the 2020 deadline coming up, many organizations are still in the dark about what the MDR is and what it means for them. Here are some common questions we’ve heard about this new European regulation and what it means for your product development and compliance activities.
There’s so much work that already goes into the development of life science products before even thinking about the necessary compliance steps. This high volume of work often leads development teams to push away compliance activities until later on, which can actually lead to rework and other negative consequences. Yet one compliance avenue that can get folded into this shuffle is your product’s use specification.
Attendees at NAVIGATE2019 get the opportunity to peek underneath the hood of Cognition and see a bit of our inner workings. This is an important aspect of why we hold these user conferences, as it promotes transparency and fosters a collaborative method of serving our customers. To that end, we have a handful of exciting presentations lined up for this year’s user conference that will be enlightening for all in attendance.
So, you’ve decided to adopt a compliance software tool into your life science organization as part of your product development activities. Congratulations! Now that you’ve made that big decision, here comes the tough part: transition and implementation.
It’s conference season again, which means only one thing: NAVIGATE2019 is upon us!
Does your life science organization need to adopt a compliance software tool?