Our blog navigates product development and compliance for the life science industry. Our solutions save time and money, delivering products with less risk.
Cultivating Risk Focused Design Instincts
Webinar On Demand: Why Flexibility and Support Matter for Effective Risk Management
Subscribe to the blog and get this guide for free
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
1 (781) 271-9300
24 Hartwell Avenue,
Lexington, Massachusetts 02421