Medical Device and Pharmaceutical Product Development and Compliance

Cognition Blog

Our blog navigates product development and compliance for the life science industry. Our solutions save time and money, delivering products with less risk.

Cognition Corporation

At Cognition, our goal is to provide medical device and pharmaceutical companies with collaborative solutions to the compliance problems they face every day, allowing the customer to focus on their products rather than the system used to create them. We know we are successful when our customers have seamlessly integrated a quality system, making day-to-day compliance effortless and freeing up resources to focus on product safety and efficacy.

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Medical Device | Risk Management | Compass | Design | compliance | Regulations

How to Speed Time to Market: Our CEO’s Take on Emerging Challenges and Acceleration Opportunities for Medical Device Companies

By: Cognition Corporation
March 19th, 2024

A Q&A With Gerald Wesel, Cognition Chairman and CEO Gerald Wesel, Cognition’s Chairman and CEO, is responsible for setting the company’s strategic direction. He is known for propelling innovative, disruptive technology companies to next level success, and has previously served in leadership roles at seven startups and four large enterprises. In this Q&A, he provides his take on how medical device development is evolving—and the persistent and emerging challenges that device companies are facing as a result. He also shares some key strategies that device company leaders should be employing to help their organizations adapt and thrive.

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cockpit | Cognition News

Cockpit 10 Release: Feature Roundup | Cognition Corporation

By: Cognition Corporation
February 15th, 2021

Giving customers more time to focus on developing great products. If you are part of a product development team, you know how tedious and time-consuming documentation can be to manage in various word or excel files. We set out to solve that problem over 10 years ago when we launched our solution, Cockpit. Our goal was to provide a unified and scalable environment to enable companies to structure data and automate processes for more efficient and accurate product development.

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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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design controls | Medical Device | Compass

Mitigate the Risk of an FDA Form 483 with an Automated Solution

By: Cognition Corporation
July 27th, 2020

Commonly issued after an FDA inspection, a Form 483 informs a company of observations requiring corrective actions. The Form 483 is often referred to as “Inspectional Observations” as it is a list of conditions or practices that indicate a potential violation of FDA requirements. The form is compiled in order of importance and is considered a snapshot of potential issues; it should not be considered all-encompassing.

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Thought Leadership

Adopting Compliance Software Tools Promotes Long-Term Growth

By: Cognition Corporation
November 27th, 2019

There are many immediate short-term benefits a compliance software tool can provide to your life science organization: improved documentation, streamlined day-to-day compliance activities, project data unification, and other advantages. But there are many important long-term benefits that may get overlooked. When deciding to adopt these software tools, it’s important to understand how they can promote growth and innovation at your company.

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Thought Leadership

3 Important Guidance Documents on Digital Health Products

By: Cognition Corporation
November 21st, 2019

The market for digital health products is rapidly expanding. Reports from Global Market Insights, Inc. project the value of this marketplace to expand to $504.4 billion by 2025. Many life science organizations have seen the opportunity these technologies can provide and are jumping at it. However, this boom in the industry has not gone unnoticed; in recent years, FDA has been rapidly transforming their policies and organization to handle the necessary regulatory work these digital health products bring to the table.

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Product Development | Thought Leadership | Risk Management

How Engaging Patients Benefits Life Science Product Development

By: Cognition Corporation
November 19th, 2019

Your product’s intended patients have a wealth of experience and information that can be valuable to your development process. Whether it’s the day-to-day realities of the condition, the symptoms they feel need the most attention, or things they might be missing in their current treatment regimens, this data cannot be elicited from doctors and engineers alone.

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Thought Leadership

3 Commonly Cited Design Controls in FDA Form 483s

By: Cognition Corporation
November 14th, 2019

FDA Form 483 Inspectional Observations are one of the many tools the agency uses to verify medical device products do not expose users and patients to undue risk. Many of the commonly cited observations involve some aspect of design controls regulations, which is of particular concern for development teams and manufacturers. Of the 438 inspectional observations in FY2017, FDA cited three design controls regulations more commonly than all others:

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Thought Leadership

4 Reasons Your Life Science Organization Should Adopt Compliance Software

By: Cognition Corporation
November 12th, 2019

Deciding to adopt a compliance software tool is not always a straightforward process. There are a number of aspects that need to be addressed—potential quality system issues, user adoption, and so on. Despite these concerns, however, there are some clear benefits to software adoption that should be taken into account. From improving documentation to establishing greater accountability, there are four distinct reasons to consider adopting compliance software.

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Thought Leadership | Industry Updates

How to Plan Ahead for the EU MDR Transition

By: Cognition Corporation
November 7th, 2019

By May 2020, the new European Union Medical Device Regulation (EU MDR) will be fully implemented. Medical device manufacturers now need to comply with a set of new and critically important regulations. While this deadline is fast arriving, there is still time to plan ahead. To make that planning as effective as possible, there are several key approaches your organization should think about taking.

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