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Notable Changes in the new FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions The FDA released its new draft guidance for the Content of Premarket Submissions for Device Software Functions on November 4, 2021. Once approved, this guidance will replace the preexisting Guidance for the Content of Premarket Submissions for Software […]
In this post, we highlight and summarize parts of the new “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.” It is important to note that this content contains non-binding guidance and therefore is not currently for implementation. With that said, while […]
One of the early steps I advise my clients to take when developing their medical device is to determine the class and classifications of their medical device. In conjunction with the complexity of the device, understanding the class and classification sets the foundation for your product development timeline and effort. This post gives a basic […]
In many ways 2021 was a continuation of the changes brought about in 2020, a year that’s been described as “unprecedented” and “unparalleled.” In a unique way, 2021 has offered us an idea of evolving innovations and technology on the horizon for teams across industries. These changing conditions will present a variety of new landscapes and will […]
Complying with FDA Design Control Requirements Using Requirements Management Principles Mercedes Massana: So agenda for today is we’re going to talk a little bit about the design controls and what they are. We’re going to talk about requirements management and what that is. And then we’re going to talk about how the two relate to […]
Design Controls have been an FDA Quality System Regulation since 1997. Having worked on developing products in the regulated medical device industry for over 35 years, I have compiled a list of the five key takeaways for implementing design controls and achieving success in commercializing medical devices: Design Controls not only help achieve regulatory compliance, […]
This post on Software as a Medical Device (SaMD) development is written by Mercedes Massana, the Principal Consultant of MDM Engineering Consultants. SaMD software is software intended to be used for one or more medical purposes that do not require embedding in a medical device. These purposes can range anywhere from helping to diagnose or […]
The US Food and Drug Administration (FDA) has issued new guidance that expands the Abbreviated 510(k) Program for medical device development and premarket notification submissions.