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 | Medical Device | Product Development | Risk | Risk Management

Beyond Excel, Managing Risk in Medical Device Development

By: David M. Cronin
August 17th, 2021

Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to a patient. Why? Because many medical devices are complex, with hundreds to thousands of inter-related design inputs/outputs, testing, and risk management data. Managing that amount of data manually is nearly impossible when using tools like Word and Excel...

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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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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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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?

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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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design controls | Thought Leadership

6 Questions to Guide Your Design Controls Documentation

By: Cognition Corporation
October 29th, 2019

Do you want to improve your design controls documentation? If so, the first step is to evaluate how your current processes and procedures are working and how effective their results are. To work through this process, there are six important questions to ask, ranging from your design outputs and risk management to the current state of your product data across multiple sites. Answering these questions thoroughly and honestly can empower greater levels of design controls compliance in your premarket submission activities.

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