Do you want to improve your design controls documentation? If so, the first step is to evaluate how your current processes and procedures are working and how effective their results are. To work through this process, there are six important questions to ask, ranging from your design outputs and risk management to the current state of your product data across multiple sites. Answering these questions thoroughly and honestly can empower greater levels of design controls compliance in your premarket submission activities.
Generating and managing your compliance documentation for premarket submission takes a lot of time and effort. And when there are inconsistencies or other major issues, especially when it comes to design controls, a number of adverse effects could impact your organization. From time lost to remediation to delays to market, it can seriously cost your life science organization. To combat these issues, you can use a number of tactics to improve your design controls documentation.
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Internal auditing is an important activity for life science organizations not just during product development, but through the overall product life cycle as well. It allows your business to self-monitor according to the necessary quality management system (QMS) rules and requirements laid out by FDA and other regulatory bodies. But some organizations might find themselves struggling with this compliance aspect: how do you ensure your internal auditing is up to standard? Here are four steps you can take to improve your auditing capabilities and efficacy.
Submitting your life science product for premarket review is a stressful endeavor; if it is rejected by regulators for insufficient documentation or other issues, it can result in lost time to market and loss of time and resources in remediation. Overcoming those issues is not an easy thing, and knowing what to do is not readily apparent. However, there are three important strategies your organization can use to improve your premarket submission documentation, potentially reducing the likelihood of rejection.
Congratulations! So, you’ve decided to adopt a compliance software tool for your life science organization. However, you’re only at the start of a big implementation process—one that has a lot of moving parts and work attached. How do you make the start of using compliance software the best process it can be?
Have you heard the term “fuzzy front end” (FFE) before? What does that even mean?
Implementing a new compliance software tool into your organization isn’t easy. Between establishing new processes, evaluating impacts on your quality system, and determining short- and long-term timelines of adoption and use, there are a lot of considerations to be managed. On top of that, getting your teams to use the tool is an entirely different challenge; if there’s resistance, then things only get more complicated. So how do you promote user adoption for new compliance software?
September 2019 saw the release of several final guidance documents relating to 510(k) submissions. One of the most utilized pathways by medical device manufacturers, the 510(k) has evolved quite a bit over time. The release of all these new documents speaks to FDA’s commitment to keeping this method of premarket submission up-to-date and aligned with agency directives. Taking a brief, high-level overview of each of these final guidance documents is extremely important for organizations looking to stay ahead of the ever-changing regulatory landscape.
In September 2019, FDA released final guidance on its Special 510(k) Program. This optional pathway allows medical device manufacturers a simplified approach to submitting changes to their legally marketed products, provided they are currently well-understood by the agency. However, figuring out whether or not your submission qualifies under the Special 510(k) is tricky. Diving into the final guidance, there are hallmarks you can use to understand your device’s qualification under this program.