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.

How Adopting Compliance Software Tools Promotes Long-Term Growth

3 Important Guidance Documents on Digital Health Products

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 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

FDA Pulse Check: October 2019

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

FDA Pulse Check: September 2019

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 for Streamlining Your Search for Compliance Software Tools

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

A Brief Recap of NAVIGATE2019

FDA Pulse Check: August 2019

Drug Stability Reporting for Pharmaceutical Companies

Common Questions About the Upcoming EU MDR

Developing Better Use Specifications for Life Science Products

What Will You Hear from Cognition at NAVIGATE2019?

7 Questions to Guide Compliance Software Adoption in Your Organization

Why Come to NAVIGATE2019?

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

NAVIGATE2019: An Early Preview of Key Talks and Presentations

7 Reasons to Consider Adopting Compliance Software Tools

FDA Pulse Check: July 2019

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

Correcting 6 Common 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 Maintaining Productivity in Life Sciences

8 Reasons to Attend NAVIGATE2019

FDA Pulse Check: June 2019

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

FDA Pulse Check: May 2019

How Can Design Thinking Impact Design Controls?

Best Online Resources for Life Science Industry News

9 Methods for Improving 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

FDA Pulse Check: April 2019

6 Must-See Talks at the 2019 INCOSE Healthcare Conference

Common Concerns for Developing Life Science Products That Address Mental Health

9 Sources of Design Inputs for Life Science Product Development

5 Reasons to Attend the 2019 INCOSE Healthcare Conference

4 Reasons Your Transition Between Innovation & Design Controls is Struggling

FDA Pulse Check: March 2019

Cognition’s 11 Most Popular Risk Management Blog Posts of 2018

5 Foundations of Robust Life Science Risk Management Programs

What the 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

FDA Pulse Check: February 2019

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

FDA Pulse Check: January 2019

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

FDA Pulse Check: 2018 in Review

4 Data Integrity Features You Want in Compliance Software Tools