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.
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?
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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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.
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.
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.
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.
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.
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?
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.