Medical Device and Pharmaceutical Product Development and Compliance

Cognition Blog

Our blog navigates product development and compliance for the life science industry. Our solutions save time and money, delivering products with less risk.

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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….

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Medical Device | Product Development | Compass

Only a Comprehensive Process Can Deliver True Quality in Medical Device Development

By: Ansgar Liening
August 27th, 2020

Often in medical device product development, functions exist in silos. Risk, requirements, and test management functions often exist separately, on their own - different systems, different teams, different objectives. Yet, the data related to these functions are both continuously changing and highly dependent on one another. Some type of process is needed to (1) manage the effect of changes across all three systems and (2) provide evidence of a process for notified bodies if and when needed.

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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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design controls | Medical Device | Compass

Mitigate the Risk of an FDA Form 483 with an Automated Solution

By: Cognition Corporation
July 27th, 2020

Commonly issued after an FDA inspection, a Form 483 informs a company of observations requiring corrective actions. The Form 483 is often referred to as “Inspectional Observations” as it is a list of conditions or practices that indicate a potential violation of FDA requirements. The form is compiled in order of importance and is considered a snapshot of potential issues; it should not be considered all-encompassing.

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