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

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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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

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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Thought Leadership

What is (Inherent) Safety by Design?

By: Nick Schofield
June 13th, 2018

In the life science product industries, you hear this FDA position on risk management all the time: your product must be developed with (inherent) safety by design. However, what that means and what it entails can sometimes be difficult to pin down. How exactly do you define and address it?

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Thought Leadership

4 Innovative Telehealth-Integrated Medical Devices

By: Nick Schofield
June 7th, 2018

We’re at the brink of a transformative era in healthcare. Technological advancements are reshaping diagnostics and care; meanwhile, our knowledge and understanding of our health is rapidly accelerating as more data is gathered and analyzed.

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Thought Leadership

510(k)s vs. Premarket Applications: What’s the Difference?

By: Nick Schofield
May 31st, 2018

When you’re preparing your medical device for regulatory submission, you want to make sure you do it right the first time. A rejection from FDA due to inadequate or inappropriate documentation can eat up time and money your team might not have—especially if you’re a smaller organization trying to get an innovative product to market. Whether you’re submitting a 510(k), a Premarket Notification (PMA), or other, specialized exemption notifications, you want to make sure whatever documentation you submit meets regulatory requirements and can provide the evidence FDA expects to see. But what’s the difference between these notifications, and how do you determine which one applies to your device?

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Thought Leadership

Submitting a 510(k) Based on Performance Criteria? You Can Do That?

By: Nick Schofield
May 29th, 2018

Yes, you can! This past April, FDA released new guidance—Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria—detailing how medical device manufacturers can leverage performance criteria in submitting an Abbreviated 510(k). But how does this differ from the traditional methods of demonstrating substantial equivalence through direct comparison, how would this expansion of the Abbreviated 510(k) work, and what is expected of you?

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Thought Leadership

3 Challenges in Validating Product Development Software for Life Science Companies

By: Nick Schofield
May 24th, 2018

Validating product development software tools and solutions used in your life science organization can be exhausting. While essential for regulatory compliance, validation can become complicated if your personnel and product development process are not well-equipped to manage it.

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