Navigating Product Development and Compliance

Helping to navigate product development and compliance for the life science industry. Our SaaS-based solutions enable customers to structure their data and automate compliance processes with built-in quality templates and automated generation of deliverables to save time and money, delivering their products to market faster with less risk.

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Thought Leadership

10 Tips for Streamlining Your Search for Compliance Software Tools

By: Cognition Corporation
September 17th, 2019

Your organization has decided it needs a compliance software tool—now what? Well, conducting a search is a good place to start. However, your search for a new tool needs to be well-informed and methodical. Otherwise, you might wind up with a tool that’s not mature enough or inappropriate for your needs. To avoid these issues and streamline your search, here are some tips that can help.

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Thought Leadership | Industry Updates

What Do You Need to Comply with the EU MDR Postmarket Requirements?

By: Cognition Corporation
September 12th, 2019

The deadline for the official implementation of the EU Medical Device Regulation (MDR) is approaching. By May 2020, your medical device organization must be in compliance with many new requirements for your product throughout its life cycle. With this increased focus on the total product life cycle comes an expanded suite of regulations for postmarket surveillance you must be in compliance with. There is a lot to unpack in this aspect of EU MDR, but there are some major compliance areas your organization should be putting in place now.

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How to Approach Usability Engineering & Use Error Analysis

Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management.

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Cognition News | NAVIGATE

A Brief Recap of NAVIGATE2019

By: Cognition Corporation
September 10th, 2019

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.

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Thought Leadership | Industry Updates

FDA Pulse Check: August 2019

By: Cognition Corporation
September 4th, 2019

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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Cognition News | Drug Stability

Drug Stability Reporting for Pharmaceutical Companies

By: Olivia O'Brien & Brigitte Cronin
August 29th, 2019

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.

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Thought Leadership | Regulatory Compliance

Common Questions About the Upcoming EU MDR

By: Cognition Corporation
August 27th, 2019

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.

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Thought Leadership

Developing Better Use Specifications for Life Science Products

By: Cognition Corporation
August 22nd, 2019

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.

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Cognition News | NAVIGATE

What Will You Hear from Cognition at NAVIGATE2019?

By: Cognition Corporation
August 20th, 2019

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.

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Thought Leadership

7 Questions to Guide Compliance Software Adoption in Your Organization

By: Cognition Corporation
August 15th, 2019

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.

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