Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
The Roles Substantial Equivalence and FDA’s Least Burdensome Provisions Play in Premarket Notification
5 Methods of Risk Control for Life Science Products
Subscribe to the blog and get this guide for free
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
You’re Invited to the 2019 INCOSE Healthcare Working Group Conference
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
FDA Pulse Check: December 2018
The Challenges of Mobility in Life Science Risk Management
How to Bolster Design Validation Compliance
Do You Still Believe These 7 Common Risk Management Myths?
4 FDA Trends Medical Device Manufacturers Should Watch in 2019
4 Risk Management Concerns for Mobile Medical Apps
3 Principles for Better Usability Risk Management
FDA Pulse Check: November 2018
How to Keep Your Medical Device Organization Prepared for Regulatory Inspection
4 Tools and Strategies for Improving Complaint Management
What Your Development Team Can Learn from Users Hacking Their Medical Devices
Validating Product Development Software: Tips and Tricks
5 User Needs Driving the Future of Medical Devices
5 Auditing Features You Want in Your Life Science Product Development Software
6 Best Practices for Implementing Compliance Software Tools in Your Life Science Organization
Risk-Benefit Analyses: The Importance of Context and Iteration
FDA Pulse Check: October 2018
What Industry 4.0 Means for Medical Device Manufacturing
Evaluating the Cybersecurity Risks of Your Medical Device
5 User Needs Considerations in Life Science Risk Management
4 Benefits of Industrial Robotics in Medical Device Manufacturing
FDA’s Proposed 2019 Draft Guidance: What Could it Mean for Your Medical Device Organization?
3 Reasons to Conduct Preliminary Hazard Analysis on User Needs
How Can Risk Libraries Benefit Your Risk Management Activities?
FDA Pulse Check: September 2018
Cognition Hosts NAVIGATE2018
Applying Design Thinking to Risk Management in Life Sciences
7 Stakeholders to Consider While Developing Your Life Science Product
3 Key Benefits of the Business Model Canvas in Life Science Product Innovation
FDA’s Quality in 510(k) Review Program Pilot—A New Approach to Premarket Notification?
FDA Pulse Check: August 2018
Process Validation in Life Sciences is Important—Here are 3 Reasons Why
3 Overlooked Risk Areas in Your Life Science Product’s Lifecycle
Cockpit®, Systems Engineering, and the Mahola Project: Developing Healthcare Systems in Cameroon
3 Key Compliance Aspects of Your Medical Device’s Use Specification
The Relationship Between Design Reviews and Risk Management
Cognition’s Summer Internship Program: Meet our Interns!
FDA Pulse Check: June/July 2018
How Can Work Instructions Help Empower Regulatory Compliance in Product Development?
Annual Cognition Clambake 2018
3 Ways Rapid Prototyping Empowers Medical Device Risk Management
Voice of the Customer, User Needs, and Iteration in Life Sciences Product Development
What Does FDA Mean by “Least Burdensome” Anyway?
4 Common Questions About Predicate Devices for 510(k) Submissions
FDA Pulse Check: May 2018
What is (Inherent) Safety by Design?
4 Innovative Telehealth-Integrated Medical Devices
510(k)s vs. Premarket Applications: What’s the Difference?
Submitting a 510(k) Based on Performance Criteria? You Can Do That?
3 Challenges in Validating Product Development Software for Life Science Companies
A Robust Approach for Validating Product Development Software [WEBINAR]
Struggling with Design Review Compliance? Ask Yourself These 3 Questions
5 Team Members You Want at a Design Review
FDA Pulse Check: April 2018
5 Signs You’re Stuck in the “Innovation Gap”
Cognition Cockpit Spring Training - June 6 & 11-15
CDRH Reorganization: How Will It Impact Your Medical Device Organization?
What's New with Cognition?
FDA Pulse Check: March 2018
Classify Your Medical Device: Class III
Taking Care of the Cognition Crew
4 US Cities with Thriving Life Science Sectors
3 Tips for Journey Mapping in Life Sciences Innovation
You're Invited to the INCOSE Healthcare Working Group 4th Annual Systems Engineering in Healthcare Conference!
What in the World is the "Fuzzy Front End" of Innovation?
FDA Pulse Check: February 2018
4 Technologies Transforming Life Science Innovation in 2018
Classify Your Medical Device: Class II
3 Myths of Life Science Innovation You Still Believe
FDA Pulse Check: January 2018
Classify Your Medical Device: Class 1
Why is Apple’s New Medical Device Accessory So Important?
Will FDA Require These 3 Controls for Your Device Compliance?
We Went to FDA SOP Training!
FDA Pulse Check: Novemeber/December 2017
Cognition Corporation Announces Appointment of New CTO
FDA's Class II Special Controls Designations Are On The Rise; How Will Your Device Be Affected?
Human Factors and Your Supply Chain
FDA Pulse Check: October 2017
Use Error and Medical Devices: Did You Consider These Four Scenarios?
3 Questions to Help Your Team Balance Cybersecurity & Usability
Ad Hoc Design Reviews: Do I Need to Document Them?
Annual Cognition Clam Bake 2017
Can Color be a Risk Factor in Medical Device Design?
At-Home Medication Errors Are On The Rise: Why?
The Complication of Risk Priority Number
New Part 11 Guidance: What You Need to Know
The Implications of WannaCry on Medical Devices: How Interconnected Devices Can Exacerbate Cyber Attacks
4 Benefits of Agile Product Development in the Medical Device Industry
Multi-Tenancy for SaaS
GAMP® 5 and why it's Relevant
AAMI TIR36, More Fun with Validation
Biomanufacturing Summit 2017: Developing Your Company’s Next Breakthrough
Verification & Validation: A Necessary Activity
How we Improve the Cockpit Platform
Behind the Scenes: Cognition's User Conference 2017
Northeastern University, REV, and Cognition Corporation
3 Obstacles Hindering Innovation
3 Difficulties in Design Controls
6 Benefits of Networking at Conferences
Cognition's Remote Training: The Facts
The Global Unique Device Identification Database (GUDID)
Do Product Development Tools Actually Save your Company Money?
The Cockpit Crew Invades Chicago for the American Medical Device Summit 2016
Everyday Items and their Rigorous Product Development
Cognition's Human Factors Engineering Class: The Experience
Fitness in the Workplace
Old School versus New School Management
6 Reasons Your PLM and PDM Are Getting Smarter Than Ever
Cognition Partners with M2D2 Massachusetts Medical Device Development Center
Basic Medical Device Commercialization
Quality or Carelessness?
21 CFR 820.30 for Dummies (i.e. Me)
Where are my Requirements?!
The E-Doctor: Your New Personal Doctor
Telemedicine - The Future of Medicine?
Medical Device Tax Suspension - Blessing or Curse?
The Difference between Verification & Validation
The Impact of Smartphones as Medical Devices
Process Meets Productivity: Installment 1
ARRGGG! My Engineers Spent More Time Understanding the Platform Than Working In It! - Increase Productivity with the Cockpit Platform
Catheters and Tomahawk Missiles, They Aren’t That Different—Are They?
The Power of Cockpit: Talking 820.30 Design Controls
Michelle's Moment: New Revision for ISO 62366-1 Application of Usability Engineering
Michelle's Moment: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
Michelle's Moment: FDA Provides Clarification on "Add-to-File" Process
Michelle's Moment: New FDA Draft Guidance Patient Preference
Michelle's Moment: Expedited Access for Premarket Approval and De Novo Medical Devices
Michelle's Moment: FDA Draft Guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the U.S.
Michelle's Moment: CDRH Seeks Participants for the Electronic Submission for Home Use Device Labeling Pilot Program
Michelle's Moment: Regulatory Guidance - Safety Considerations to Mitigate the Risks of Misconnection with Small-bore Connectors
Michelle's Moment: Regulatory Compliance - Reprocessing Medical Devices in Health Care Settings
Michelle's Moment: FDA Speaks Out to Congress on Innovation
Michelle's Moment: FDA Case Study - Bringing Low to Moderate Risk Devices to Market
Michelle's Moment: Final MDDS Guidance Last in a Trifecta to Get Lower Classification Device to Market with Fewer Regulations
Michelle's Moment: Regulatory Change - Moving Toward a National Medical Device Postmarket Surveillance System
Michelle's Moment: Medical Device Single Audit Program to Ensure Regulatory Compliance
Michelle's Moment: Regulatory Compliance - Patient Preference When Considering Risk-Benefits of New Device Approval
Michelle's Moment: New FDA Draft Guidance - Medical Device Accessories
Michelle's Moment: FDA FY2015 Plan for Guidance Document Development and Review
Michelle's Moment: FDA Guidance: Transfer of a Premarket Notification Clearance
Michelle's Moment: FDA Forms Pharmacy Compounding Advisory Committee
Michelle's Moment: New FDA Guidance - Infusion Pump Guidance
Michelle's Moment: New FDA Guidance - LATEX FREE?
All posts
