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.
After participating in and sponsoring the INCOSE Healthcare Working Group’s 5th Annual Systems Engineering (SE) in Healthcare Conference, we wanted to take some time on our blog to reflect on our experience, as well as share some of the things we learned.
The 2019 INCOSE Systems Engineering (SE) in Healthcare Conference is quickly approaching, and Cognition is excited to be there this year. The conference is set to be two days of informative talks, networking, and fun for all in attendance. The INCOSE Healthcare Working Group recently released the tentative conference program, and here we’re highlighting six talks for attendees.
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The 5th Annual Systems Engineering in Healthcare Conference is set for this spring, and Cognition will be in attendance. We encourage you to join us May 1-2, 2019 for a couple of days of informative talks, panels, discussions, and networking.
September 20-21, Cognition hosted our user conference—NAVIGATE2018—at the Long Wharf Marriott Hotel in Boston. This year was packed to the brim with great talks, discussions, and opportunities to network. Read on to catch some highlights from this year’s conference.
It can sometimes seem, in life science product development, that everything needs to be validated. From the design of your product to the computer systems you utilize in your design controls and risk management activities, regulatory bodies ask for validation. And processes have no exception from validation requirements.
Our Cockpit platform is powerful guided compliance software, and at its heart is a deep focus on systems engineering. Many of Cockpit’s features, while aligned to regulations and standards for design controls and risk management, also allow our customers to develop and manage the complex designs of a product’s systems throughout its lifecycle. The systems engineering tools built into Cockpit have been repurposed for a manner of other projects beyond life science product development.
Summer is here, and Cognition’s internship programs are back in full swing. From marketing to quality assurance and software development, we take on individuals looking to build their skills and work in a team environment. This summer, we’ve got six interns, three of them returning from previous years. Find out more about them and what they’ve been up to so far with Cognition!
It’s that time of year again: school is out, the beaches are packed, and the grills are hot. To celebrate the season and the hard work of all our Cognition employees, we recently hosted our company clambake.
If you’re employing a software solution in developing your life science products, then your product design isn’t your only validation challenge. On top of all your team’s regular activities, you have to complete regular validation of the software tools you use in product development as well. However, because time to market and regulatory compliance for your life science products are critical, software validation inevitably gets pushed off for later. Either that, or you have to outsource it to third-party firms and consultants.