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.

Are You Leading or Falling Behind? How Innovative Medical Device Manufacturers are Modifying Their Design Control Process

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

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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How to Identify an Effective Medical Device Design Control Software Platform: 9 Key Considerations

Rising Risk: Why Many Medical Device Companies Are In Danger of Risk Analysis Missteps

How Medical Device Companies Can Leverage Real-Time Traceability to Speed Up Development, Increase Accuracy

Stay Ahead of the Curve: 10 Ways to Achieve Medical Device Compliance

Cultivating Risk Focused Design Instincts

Webinar On Demand: Why Flexibility and Support Matter for Effective Risk Management

Space and Time. Are You Considering the 4th Dimension in Product Development Data?

No Room for Error: The Importance of Managing Change

Three Key Questions for Assessing Medical Device Risk Management Tools

Reusability: Data Duplication to Accelerate Medical Device Development

Beyond Excel, Managing Risk in Medical Device Development

Top 3 Reasons Med Device Should Invest in Structured Data | Cognition

Cockpit 10 Release: Feature Roundup | Cognition Corporation

Best Practices for a Quality System Based Design Process

Accelerate Medical Device Development with Systems Engineering

The Importance of Linking User Needs with Design Requirements

Only a Comprehensive Process Can Deliver True Quality in Medical Device Development

Complying with ISO 14971:2019

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

Adopting Compliance Software Tools Promotes Long-Term Growth

3 Important Guidance Documents on Digital Health Products

How Engaging Patients Benefits Life Science Product Development

3 Commonly Cited Design Controls in FDA Form 483s

4 Reasons Your Life Science Organization Should Adopt Compliance Software

How to Plan Ahead for the EU MDR Transition

3 Reasons Why People Choose the Cockpit® Platform

6 Questions to Guide Your Design Controls Documentation

How to Improve Your Design Controls Documentation

4 Steps to Better Internal Auditing in Life Science Product Development

3 Ways to Improve Your Premarket Submission Documentation

Best Practices for Implementing Compliance Software into an Organization

"Fuzzy Front End": What is it?

Strategies for Promoting User Adoption of Compliance Software Tools

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

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

10 Tips to Simplify Your Search for Compliance Software Tools

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

A Brief Recap of NAVIGATE2019

Drug Stability Reporting for Pharmaceutical Companies

Common Questions About the Upcoming EU MDR

Developing Better Use Specifications for Life Science Products

7 Questions to Guide Compliance Software Adoption in Your Organization

How to Tell if Your Life Science Organization Needs Compliance Software Tools

7 Reasons to Consider Adopting Compliance Software Tools

6 Quick Facts About FDA’s Medical Device Development Tools Program

Correcting 6 Misunderstandings About FDA’s Design Controls Regulation

5 Questions to Ask After Completing Design Reviews

Why Take the Compliance-First Approach in Life Science Product Development?

3 Reasons to Worry about FDA Form 483s for Design Controls

4 Organizational Changes for Productivity in Life Sciences

6 Ways to Make Your Life Science Product Development More Productive

4 Factors Influencing User Needs for Younger Patients

A Refresher on FDA Form 483s and Inspectional Observations

7 Ways to Bolster Your Risk Analysis

What Factors Impact the Quality of Drug Stability Reports?

How to Write Effective CTQs for Your Life Science Product

How Can Design Thinking Impact Design Controls?

Best Online Resources for Life Science Industry News

9 Ways to Improve Your Life Science Product Development Processes

8 Benefits of Centralizing Your Product Development Data

Understanding Patient Preferences in Life Science Product Development

3 Quick Tips for Improving Compliance with Design Controls

8 Important Facts About FDA’s New Office of Product Evaluation and Quality

7 Ways to Bolster Your Life Science Risk Management Programs

Common Concerns in Developing Life Science Products for Mental Health

9 Sources of Design Inputs for Life Science Product Development

4 Reasons Your Transition Between Innovation & Design Controls is Struggling

5 Foundations of Robust Life Science Risk Management Programs

What Safety and Performance 510(k) Means for Medical Device Manufacturers

The 5 Steps of Iterative Risk Management

6 Critical Aspects of Your Life Science Product’s Design & Development Plan

The Roles Substantial Equivalence and FDA’s Least Burdensome Provisions Play in Premarket Notification

5 Methods of Risk Control for Life Science Products

7 Takeaways from FDA’s “Clinical Data in Med Device Submissions” Guidance

Risk Control and Life Science Product Development: Influencing Factors and Guiding Principles

Organizational Growth and Compliance in Life Science Industries

What’s Slowing Your Life Science Organization’s Growth?

7 Modern Risk Factors for Medical Devices

Top 5 Public Health Concerns Life Sciences Can Address

Should You Use Open Access Data in Your Life Science Product Development?

6 Risk Factors Impacting Your Medical Device Labeling

Understanding FDA’s Least Burdensome Provisions

Strategies for Fostering Innovation in Life Sciences

What are Essential Outputs for Design Controls Compliance?

7 Reasons You’re Struggling with Your Design History File

Is Your Life Science Organization Leveraging These 4 Risk Management Tools?

4 Ways to Improve Your Life Science Product Development in 2019

4 Data Integrity Features You Want in Compliance Software Tools