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.
As part of an Agile approach to product development, defined user needs help streamline your design and compliance activities for your life science product. But how do you develop those user needs in the first place?
Interactions with FDA are an inevitable part of the lifecycle of your life science products. From premarket activities to postmarket surveillance, interacting with regulatory officials is necessary, and can be valuable to your organization.
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If you’re working on a medical device 510(k) submission for the first time, it can feel like a daunting task. On top of your regular design work, you have to prove your device is similar to legally marketed predicate devices that already have been cleared by FDA. While FDA provides plenty of resources for supporting your 510(k) efforts, questions can pop up that aren’t always so straightforward to resolve. Here are some of the most common questions, and answers to help clear things up.
The FDA Pulse Check is a monthly series of blog posts from Cognition focusing on the latest news, updates, and information from FDA relating to life sciences industries.
In the life science product industries, you hear this FDA position on risk management all the time: your product must be developed with (inherent) safety by design. However, what that means and what it entails can sometimes be difficult to pin down. How exactly do you define and address it?
We’re at the brink of a transformative era in healthcare. Technological advancements are reshaping diagnostics and care; meanwhile, our knowledge and understanding of our health is rapidly accelerating as more data is gathered and analyzed.
When you’re preparing your medical device for regulatory submission, you want to make sure you do it right the first time. A rejection from FDA due to inadequate or inappropriate documentation can eat up time and money your team might not have—especially if you’re a smaller organization trying to get an innovative product to market. Whether you’re submitting a 510(k), a Premarket Notification (PMA), or other, specialized exemption notifications, you want to make sure whatever documentation you submit meets regulatory requirements and can provide the evidence FDA expects to see. But what’s the difference between these notifications, and how do you determine which one applies to your device?
Yes, you can! This past April, FDA released new guidance—Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria—detailing how medical device manufacturers can leverage performance criteria in submitting an Abbreviated 510(k). But how does this differ from the traditional methods of demonstrating substantial equivalence through direct comparison, how would this expansion of the Abbreviated 510(k) work, and what is expected of you?
Validating product development software tools and solutions used in your life science organization can be exhausting. While essential for regulatory compliance, validation can become complicated if your personnel and product development process are not well-equipped to manage it.