Guided Approach White Papers
Cognition has introduced a guided approach to compliance for medical device, pharmaceutical, and combination product industries. Download our latest white papers on our Guided Approach today to learn more about how Cognition can help you!
Use Error Analysis
Determining the intended use of the device, its functions, and user-dependent tasks is critical in the beginning of the usability engineering process. Once these are complete, activities such as Use Error Analysis help identify use errors, hazardous situations created by the use error, hazards the user is exposed to, and the potential harms that could occur. In our latest white paper, read about what each of these steps entails and how activities like Use Error Analysis can lead to more dynamic, impactful risk management.
Design Controls Template
The Cognition Design Controls Template runs on Cognition's powerful Cockpit Platform. Using this template, teams are guided through the process of Design Controls as defined by FDA in 21 CFR 820.30.
Preliminary Hazard Analysis Template
The Cognition PHA Template runs on Cognition's powerful Cockpit Platform. Using this template, teams are guided through the process of completing a PHA exercise as outlined in commonly followed standards.
Design Controls Series White Papers
Dive into this series of white papers written by Michelle Lott, founder of Lean RAQA, and Scott Wright, CEO and founder of A Wright Path, as they explore design defects and deficiencies as relating to the various sub-parts of 21 CFR 820.30. Each paper in the series outlines the breakdown of 483s issued by FDA for each given sub-part of the regulation.
Part 1: Risk Control and Usability
Risk Management and Usability are key factors to the success of product design, making them a focus point in the Design Controls discussion. Part 1 is a systematic review of 483 data and common breakdowns in 21 CFR 820.30 (c) and (d).
Part 2: Design Controls
Part 2 in the series analyzes 483 citations and design control trends. This paper focuses specifically on trends related to the first two elements of a robust design control system: procedures and planning.
Part 3: Design Input and Design Output
The third paper in the series conducts a systematic review of Form 483s issued by FDA in 2012 and 2013 and common breakdowns in 21 CFR 820.30(c) and 21 CFR 820.30(d).
Part 4: Design Review
The third paper in the series conducts a systematic review of conducts a systematic review of 483 data and common breakdowns in 21 CFR 820.30(e).
Part 5: Verification and Validation
The third paper in the series conducts a systematic review of Form 483s issued by FDA in 2012 and 2013 and common breakdowns in 21 CFR 820.30(f) and (g).
Part 6: Design Transfer
The third paper in the series conducts a systematic review of conducts a systematic review of 483 data and common breakdowns in 21 CFR 820.30(h).
Cognition Cockpit White Papers
eBook: Classify Your Medical Device for FDA Submission: A Practical Guide for Busy Medical Device Professionals
The process of device classification is nuanced—any number of factors could cause your device to fall into one class instead of the other. If you don’t have a good grasp on these factors and how device classification works, you run the risk of losing time and resources to retroactive compliance if FDA determines your device falls under a different class than what you submitted under. Download this eBook today to better understand the basics of device classification, its influencing factors, and how to leverage existing FDA resources for better determining your device’s class. This eBook is a handy, all-in-one guide for the busy medical professional looking for a simple reference to get started in compliance activities for their device’s classification.
Understanding Critical to Quality
CTQ Flowdown is a powerful methodology for prioritizing those characteristics and features of your life science product that are most important for your users. This white paper dives into this methodology, how it helps preserve customer Voices/User Needs, and the benefits of implementing it into your product development process.
Bridging Life Sciences Innovation to Formal Design Controls
In order to get your innovative life science ideas and solutions to market, they need to pass through the formal design controls process. Teams can get stuck in this transition, falling into the "innovation gap." But why does this happen, and how can you avoid it? Read this white paper to identify pitfalls that lead to the innovation gap, why they occur, and practical solutions for overcoming them.
Cockpit as SaaS
Learn how Cognition's Software-as-a-Service offerings can help remove IT burden while empowering your product development process.
Download the Cognition Cockpit Validation Kit to learn the importance of running in a validated environment. Also learn how the Cockpit Validation Kit can ease the burden of validating your Cockpit environment.
Discover the ins and outs of the comprehensive configurable workflow capabilities within Cognition's Cockpit Platform.