Product Development and Compliance Blog | Cognition

design controls | Compass | 21 CFR 820.30 | EU MDR

Best Practices for a Quality System Based Design Process

By: Sally Carter
January 27th, 2021

Imagine developing a medical device or drug that could be claimed to work without any evidence….

requirements | design controls | 21 CFR 820.30

The Importance of Linking User Needs with Design Requirements

By: Sally Carter
October 1st, 2020

There are many inputs to consider when designing a new medical device product: user needs, regulatory requirements, and internal and external customer requirements, to name a few. Finding harmony and documenting everything is not a simple paperwork exercise. This can be overwhelming to even the most seasoned medical device professional. How do you make sure the user needs are linked to actionable requirements, and ensure that all requirements have been addressed?

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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Medical Device and Pharmaceutical Product Development and Compliance

Best Practices for a Quality System Based Design Process

The Importance of Linking User Needs with Design Requirements

Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management.