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  How Minimum Viable Products Deliver the Most Valuable Products (MVP) for Medical Device Development

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  Root Cause Analysis for Medical Device Development

  Overview of tools for Root Cause Analysis is an important tool in medical device development and manufacturing.

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  5 Key Features of FDA Draft Guidance for Predetermined Change Control Plans (PCCPs) for Medical Devices

  Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework

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  How Continuous Integration Improves Medical Device Firmware

  Originally a practice at only the very largest software houses — like Google and Amazon — continuous integration (CI) has worked its…

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  Impact of New FDA Laboratory Developed Tests Policy

  The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA Laboratory Developed Tests Policy guidance document issued on June 25, 2024.

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  Choosing a Drug Delivery System Imaging Technology

  Drug Delivery System Imaging Technology options include MRI, CT, and Ultrasound. This article highlights advantages and disadvantages for each technology in guiding drug delivery.

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  Medical Device Innovation Initiatives

  We design medical devices and our medical device innovation initiatives support the energy and shared passion when team members work together in person.

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  Peer Kudos Reflect Company Culture and Values

  A selection of Peer Kudos from the past year or two that say a lot about our company culture and values.

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  How eLearning and LMS Empower Medical Device Employees

  elearning and LMS improve an employee’s ability to learn and adhere to the company QMS for medical device design and development.

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