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.

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.

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.

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.