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.
Life science product development can sometimes be a niche enterprise, and for good reason—certain populations and conditions require specific solutions and treatments. Providing these can be a boon to both patient outcomes and your organization’s bottom line, as well as progressing that particular field of treatment.
We have entered the age of big data—the volume of data gathered in healthcare alone is becoming larger and more complex as the days go by. This wealth of information has sparked the rise of open access databases for public and commercial use around the globe. All this freely available data can be a boon to innovation in life sciences. However, the risks these databases present, and the approaches regulatory agencies take toward those risks, are important considerations for your organization.
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Labeling is an important part of FDA’s quality system regulation for medical devices. So important, in fact, that labeling regulations are captured in several distinct parts of 21 CFR Subchapter H – Medical Devices. These sections cover how devices are tracked, the unique device identifiers (UDIs) and universal product codes (UPCs) necessary for that tracking, and specific labeling requirements.
First codified in the Food and Drug Administration Modernization Act of 1997, least burdensome provisions have guided all of FDA’s regulatory work ever since. The provisions impact everything from the development of new guidance documents to adjusting and improving upon existing approval pathways, and so on. Particularly with the agency’s bolstered commitment to addressing digital health products in the coming years, the least burdensome approach has never been so important. But how does FDA actually define “least burdensome” exactly, and how do they enact it?
Time to market is only part of the equation when it comes to being competitive in life science industries. The other major factor is differentiation: what does your product do that is inventive and improves outcomes for users and patients beyond the capacities of similar, legally marketed products? To build that value into your product, innovation is key.
While this was a slower month than usual due to the government shutdown, FDA has still been active. Here are a few important updates from January 2019 your life science organization may want to keep up with.
A core component of managing your medical device design is identifying and maintaining its essential outputs. However, there’s a lot of gray area when it comes to essential outputs, and the regulatory definitions aren’t always clear. In order to adequately address them in your development activities, figuring out what these outputs are is key.
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.