Medical Device Product Development

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.

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FDA | Thought Leadership

An Overview of the Latest 510(k) Submissions Final Guidance

By: Nick Schofield
September 24th, 2019

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.

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Blog Feature

FDA | Thought Leadership

Determining if Your Medical Device is Appropriate for the Special 510(k) Program

By: Nick Schofield
September 19th, 2019

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.

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How to Approach Usability Engineering & Use Error Analysis

Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management.

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