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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Medical Device | Product Development | Risk | Risk Management

Three Key Questions for Assessing Medical Device Risk Management Tools

By: David M. Cronin
September 28th, 2021

In the highly regulated world of medical device manufacturing, the relentless requirement to minimize and mitigate risk places a huge onus on design, development, and manufacturing teams. That’s why companies, large and small, are looking for software solutions to help ensure consistency and objectivity in the creation, auditing, and monitoring of critical risk management processes.

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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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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 | 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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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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Thought Leadership | Risk Management

7 Ways to Bolster Your Life Science Risk Management Programs

By: Cognition Corporation
May 2nd, 2019

Implementing a robust risk management program into your life science organization requires a solid understanding of your needs, capacities, and goals. Whether to improve alignment with regulatory requirements and standards or adjust your overall risk procedures, identifying what you can do to bolster your current risk management programs is vital to promoting long-term growth. There are many ways out there to improve your risk management, but there are a few worth using as a baseline to build on.

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Thought Leadership | Risk Management

Cognition’s 11 Most Popular Risk Management Blog Posts of 2018

By: Cognition Corporation
April 4th, 2019

The Cognition blog had a very busy 2018, and it was all thanks to readers like you. We discussed many pressing topics in life science industries, the latest FDA updates, things happening at Cognition, and so on. In reviewing blog performance in 2018, we found a number of blogs related to risk management that were very popular with our readers, and we wanted to share that list with you. 

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