Posts categorized as“Western Region”

Virginia Anastassova

510(k) submission: 9 Tips for success

A 510(k) submission is required in the U.S.to receive clearance to market almost all class II medical devices.  While the 510(k) preparation process is not as onerous as preparing a Premarket Approval (PMA), it has its own challenges and pitfalls. We recently completed a 510(k) submission and I’d like to share some of the wisdom […]

Hannah Rusak-Gillrie

How to turn patient imaging data into functional 3D models

Patient imaging data is a powerful and robust source for developing anatomically accurate and functional 3D models. Having an accurate representation of anatomy available to engineers and designers during product brainstorming and design is an invaluable resource. This blog outlines the process of creating 3D models, and innovative methods to use them throughout medical device […]

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