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.

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Thought Leadership

3 Key Compliance Aspects of Your Medical Device’s Use Specification

By: Nick Schofield
August 16th, 2018

Developing a use specification for your medical device is important—not just for your human factors/usability engineering exercises, but for compliance as well. Because the use specification summarizes characteristics related to the context of device use, it helps narrow the scope of your product and can help you align its intended use to its device type within FDA regulations.

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Thought Leadership

The Relationship Between Design Reviews and Risk Management

By: Nick Schofield
August 9th, 2018

When you’re developing a life science product, risk management is an integral part of your process. It helps you evaluate requirements and design features for hazards and potential harms. But do the resulting risk controls require a separate design review, or can they be reviewed with the design stage they flow back into?

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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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Thought Leadership | Industry Updates

FDA Pulse Check: June/July 2018

By: Nick Schofield
August 2nd, 2018

What’s happening this summer at FDA? Here are a few stories we thought were worth highlighting.

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Thought Leadership

How Can Work Instructions Help Empower Regulatory Compliance in Product Development?

By: Nick Schofield
July 31st, 2018

Most life science organizations look to meet regulatory requirements through writing and implementing standard operating procedures (SOPs). However, within SOPs there can be some nebulous areas that can adversely impact the very compliance the procedure was developed to achieve. To overcome this, some organizations implement work instructions: detailed steps to complete tasks identified within the SOP. But can these actually improve compliance? And if so, how?

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Thought Leadership

3 Ways Rapid Prototyping Empowers Medical Device Risk Management

By: Nick Schofield
July 19th, 2018

Rapid prototyping is a design activity that is beneficial throughout product development, not just during early innovation stages. Building low-fidelity models is beneficial for:

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Thought Leadership

Voice of the Customer, User Needs, and Iteration in Life Sciences Product Development

By: Nick Schofield
July 12th, 2018

As part of an Agile approach to product development, defined user needs help streamline your design and compliance activities for your life science product. But how do you develop those user needs in the first place?

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Thought Leadership

What Does FDA Mean by “Least Burdensome” Anyway?

By: Nick Schofield
July 3rd, 2018

Interactions with FDA are an inevitable part of the lifecycle of your life science products. From premarket activities to postmarket surveillance, interacting with regulatory officials is necessary, and can be valuable to your organization.

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Thought Leadership

4 Common Questions About Predicate Devices for 510(k) Submissions

By: Nick Schofield
June 28th, 2018

If you’re working on a medical device 510(k) submission for the first time, it can feel like a daunting task. On top of your regular design work, you have to prove your device is similar to legally marketed predicate devices that already have been cleared by FDA. While FDA provides plenty of resources for supporting your 510(k) efforts, questions can pop up that aren’t always so straightforward to resolve. Here are some of the most common questions, and answers to help clear things up.

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Thought Leadership | Industry Updates

FDA Pulse Check: May 2018

By: Nick Schofield
June 19th, 2018

The FDA Pulse Check is a monthly series of blog posts from Cognition focusing on the latest news, updates, and information from FDA relating to life sciences industries.

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