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.

3 Ways to Improve Your Premarket Submission Documentation

FDA Pulse Check: September 2019

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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Implementing Compliance Software Tools in Your Life Science Organization: 6 Best Practices

"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

5 Takeaways from the 2019 INCOSE Healthcare Conference

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

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?