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

Accelerate Medical Device Development with Systems Engineering

By: David M. Cronin
October 16th, 2020

Systems engineering should be used more often in medical device product development. This may be a strong statement, but it can be transformative for device development through decreased development costs, streamlining of interactions with the FDA, and reduced time-to-market. We would like to address this through a series of articles on systems engineering role in Medical Device Product Development of which this is the first.

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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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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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Medical Device | Risk | Risk Management

Complying with ISO 14971:2019

By: Ben Higgitt
August 11th, 2020

SEPARATE RISK MANAGEMENT AND FMEA FOR BETTER MEDICAL DEVICE DEVELOPMENT. The below is an excerpt of the article originally published on MDDI. FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by failures alone. A product may never fail, but there are still potentially many other risks.

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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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Thought Leadership

Adopting Compliance Software Tools Promotes Long-Term Growth

By: Cognition Corporation
November 27th, 2019

There are many immediate short-term benefits a compliance software tool can provide to your life science organization: improved documentation, streamlined day-to-day compliance activities, project data unification, and other advantages. But there are many important long-term benefits that may get overlooked. When deciding to adopt these software tools, it’s important to understand how they can promote growth and innovation at your company.

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Thought Leadership

3 Important Guidance Documents on Digital Health Products

By: Cognition Corporation
November 21st, 2019

The market for digital health products is rapidly expanding. Reports from Global Market Insights, Inc. project the value of this marketplace to expand to $504.4 billion by 2025. Many life science organizations have seen the opportunity these technologies can provide and are jumping at it. However, this boom in the industry has not gone unnoticed; in recent years, FDA has been rapidly transforming their policies and organization to handle the necessary regulatory work these digital health products bring to the table.

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Product Development | Thought Leadership | Risk Management

How Engaging Patients Benefits Life Science Product Development

By: Cognition Corporation
November 19th, 2019

Your product’s intended patients have a wealth of experience and information that can be valuable to your development process. Whether it’s the day-to-day realities of the condition, the symptoms they feel need the most attention, or things they might be missing in their current treatment regimens, this data cannot be elicited from doctors and engineers alone.

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