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The Impact of Post-EU MDR Compliance on Medical Device Manufacturers

The Impact of Post-EU MDR Compliance on Medical Device Manufacturers

The extended EU MDR transition deadline is just around the corner for manufacturers looking to sell their medical devices in the European Economic Area (EAA). Effective May 26, 2024, companies must submit a conformity assessment application and implement a quality management system (QMS) according to the latest EU MDR guidelines to obtain their product certification. Here, we review the key...

Digital Transformation in Defense Manufacturing: The DoD’s New Digital Engineering Instruction

Digital Transformation in Defense Manufacturing: The DoD’s New Digital Engineering Instruction

On December 21, 2023, the U.S. Department of Defense (DoD) released Digital Engineering Instruction 5000.97 (DoDI 5000.97)1. The DoD mandate requires new defense acquisition programs to implement digital technologies and practices for the development and sustainment of defense systems beginning in 2024. It primarily focuses on six acquisition categories: Major Capability, Middle Tier, Software,...

Navigating Uncharted Skies: The Path to UAM Commercialization

Navigating Uncharted Skies: The Path to UAM Commercialization

Today, innovators like Airbus, Volocopter GmbH, and Urban Aeronautics are making headlines with their unveiling of unmanned aerial vehicles (UAVs) and vertical take-off and landing vehicles (VTOLs). Although still in its infancy, the global urban air mobility (UAM) market is projected to reach $23.42 billion (USD) in revenue and achieve a 16.7% compound annual growth rate (CAGR) by 20321....