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

7 Reasons You’re Struggling with Your Design History File

By: Nick Schofield
January 22nd, 2019

Design history files (DHFs) are crucial for both your compliance efforts and overall product quality. However, many life science organizations still grapple with managing them well. Why?

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Thought Leadership

Is Your Life Science Organization Leveraging These 4 Risk Management Tools?

By: Nick Schofield
January 17th, 2019

Whether your life science organization is growing or already well-established, you understand the importance of risk management in product development. For both compliance and product fidelity, you need to be sure as much risk as possible is designed out of your product.

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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 Ways to Improve Your Life Science Product Development in 2019

By: Nick Schofield
January 15th, 2019

So, your life science organization has made a resolution to improve your product development activities in the new year. Now what? Many factors need to be taken into account, and stakeholders from all facets of development need to be involved. Determining how to meet your organization’s directives while finding solutions that optimize your current capacities and resources can therefore be difficult. If you find yourself stuck trying to improve your organization’s product development in the coming year, there are a handful of approaches that can help.

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Thought Leadership | Industry Updates

FDA Pulse Check: 2018 in Review

By: Nick Schofield
January 10th, 2019

No doubt: 2018 was an important—and extremely busy—year for FDA. Between engaging with the 21st Century Cures Act and applying critical updates to long-standing programs, the agency has spent the past year working hard to position itself well in the changing landscape of life science industries. While there’s a lot worth discussing about the regulatory year that was 2018, a few important milestones are worth a second look.

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Thought Leadership

4 Data Integrity Features You Want in Compliance Software Tools

By: Nick Schofield
January 8th, 2019

Data management in life sciences is a big task: not only does your team have to make sure the right data is generated, but also that it remains accurate and consistent. Robust compliance software tools can help your team bolster data integrity, provided they have the right features. There are four key data integrity features in particular that your organization should look for in any compliance software tool.

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Thought Leadership | Industry Updates

FDA Pulse Check: December 2018

By: Nick Schofield
January 2nd, 2019

The year has drawn to a close, but FDA is not slowing down its pace. December 2018 was a big month for the agency, and there’s a lot to talk about. Here are a few important updates to catch up on as we prepare to move into the new year.

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Thought Leadership

The Challenges of Mobility in Life Science Risk Management

By: Nick Schofield
December 26th, 2018

In 2016, the global market for mobile medical apps was valued at nearly $1.5 billion. However, this market is expanding so quickly—just over 20 percent per year—that by 2025, its value may increase eight-fold to over $11 billion. This massive growth, encouraged by the rapid pace of technological development, is already changing healthcare as we know it.

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Thought Leadership

How to Bolster Design Validation Compliance

By: Nick Schofield
December 20th, 2018

In FY2017, FDA handed out over 300 Form 483 observations to domestic medical device manufacturers related to issues with design controls compliance. Nearly one-third of these were for 21 CFR 820.30(g)—design validation—alone. Similar data from 2016 shows that cited design validation issues rose from 27 to 29 percent of design control observations in just one year. So what’s going on?

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Thought Leadership

Do You Still Believe These 7 Common Risk Management Myths?

By: Nick Schofield
December 18th, 2018

Risk management is an integral part of life science product development, and there are a lot of opinions out there about it. Among organizations, regulatory bodies, and other industry stakeholders, there’s no clear consensus on many aspects of risk management. As a result, a number of myths have evolved which can negatively impact product development activities. Dispelling these myths is important for incorporating a more dynamic and nuanced approach to risk management for life science products.

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