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

Best Practices for Implementing Compliance Software into an Organization

By: Cognition Corporation
October 9th, 2019

Congratulations! So, you’ve decided to adopt a compliance software tool for your life science organization. However, you’re only at the start of a big implementation process—one that has a lot of moving parts and work attached. How do you make the start of using compliance software the best process it can be?

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Thought Leadership

"Fuzzy Front End": What is it?

By: Cognition Corporation
October 2nd, 2019

Have you heard the term “fuzzy front end” (FFE) before? What does that even mean?

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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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Thought Leadership

Strategies for Promoting User Adoption of Compliance Software Tools

By: Cognition Corporation
September 26th, 2019

Implementing a new compliance software tool into your organization isn’t easy. Between establishing new processes, evaluating impacts on your quality system, and determining short- and long-term timelines of adoption and use, there are a lot of considerations to be managed. On top of that, getting your teams to use the tool is an entirely different challenge; if there’s resistance, then things only get more complicated. So how do you promote user adoption for new compliance software?

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FDA | Thought Leadership

An Overview of the Latest 510(k) Submissions Final Guidance

By: Cognition Corporation
September 24th, 2019

September 2019 saw the release of several final guidance documents relating to 510(k) submissions. One of the most utilized pathways by medical device manufacturers, the 510(k) has evolved quite a bit over time. The release of all these new documents speaks to FDA’s commitment to keeping this method of premarket submission up-to-date and aligned with agency directives. Taking a brief, high-level overview of each of these final guidance documents is extremely important for organizations looking to stay ahead of the ever-changing regulatory landscape.

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FDA | Thought Leadership

Determining if Your Medical Device is Appropriate for the Special 510(k) Program

By: Cognition Corporation
September 19th, 2019

In September 2019, FDA released final guidance on its Special 510(k) Program. This optional pathway allows medical device manufacturers a simplified approach to submitting changes to their legally marketed products, provided they are currently well-understood by the agency. However, figuring out whether or not your submission qualifies under the Special 510(k) is tricky. Diving into the final guidance, there are hallmarks you can use to understand your device’s qualification under this program.

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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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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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Cognition News | Drug Stability

Drug Stability Reporting for Pharmaceutical Companies

By: Cognition Corporation
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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