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.
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.
FDA released a number of important updates in September 2019, spanning from their premarket submission pathways to integral policy updates. Here are a few of the important highlights from the month.
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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.
Your organization has decided it needs a compliance software tool—now what? Well, conducting a search is a good place to start. However, your search for a new tool needs to be well-informed and methodical. Otherwise, you might wind up with a tool that’s not mature enough or inappropriate for your needs. To avoid these issues and streamline your search, here are some tips that can help.
The deadline for the official implementation of the EU Medical Device Regulation (MDR) is approaching. By May 2020, your medical device organization must be in compliance with many new requirements for your product throughout its life cycle. With this increased focus on the total product life cycle comes an expanded suite of regulations for postmarket surveillance you must be in compliance with. There is a lot to unpack in this aspect of EU MDR, but there are some major compliance areas your organization should be putting in place now.