Medical Device Product Development

Navigating Medical Device Design Control & Risk Management

Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.

Blog Feature

Thought Leadership | Risk Management

7 Ways to Bolster Your Life Science Risk Management Programs

By: Nick Schofield
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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Blog Feature

Thought Leadership | Risk Management

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

By: Alex Critch
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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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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Blog Feature

Thought Leadership | Risk Management

The Complication of Risk Priority Number

By: Nick Schofield
July 11th, 2017

Risk scoring has been, historically, a significant part of many risk management activities. It is a method for evaluating which risks are the most critical to control. Successive scoring of risk controls allows teams to see how the level of risk on the evaluated design, process, function, operation, etc. may improve over time. Within risk exercises such as failure modes effects analysis (FMEA), risk scoring is a multiplicative process involving three factors: severity of harm (S), probability of occurrence (O), and detectability (D). These will yield a risk priority number (RPN) that, depending on the guidelines a business has in place, will determine whether a risk is acceptable or requires risk control measures. Because these scores are often expressed on scales between 1 and 10 (least to greatest), the RPN for FMEAs has a potential scoring range between 1 and 1,000.

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