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 | Usability

Use Error and Medical Devices: Did You Consider These Four Scenarios?

By: Nick Schofield
September 27th, 2017

In your product development cycle, your teams get heavily involved in usability engineering—particularly during risk management. This process is meant to be intensive: the more exhaustive your team’s efforts in identifying as many user interactions as possible, the greater benefits they yield. FDA is then satisfied you have applied their “Inherent Safety by Design” principle, and there is less overall risk to the user.

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Blog Feature

Thought Leadership | Usability

3 Questions to Help Your Team Balance Cybersecurity & Usability

By: Nick Schofield
September 13th, 2017

With the growing risks of potentially fatal hacks of interconnected medical devices, FDA is more concerned than ever that product development teams are incorporating robust cybersecurity measures into their device design. No matter what measures teams decide to implement, FDA’s main concern is for maximizing user safety while mitigating risk as much as possible.

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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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