Guest Columns

91. Data-Driven Trends In Predetermined Change Control Plans 7/12/2024

    The FDA introduced the concept of the predetermined change control plan to address the dynamic nature of medical devices, particularly those using software and AI. Bridging Consulting conducted a data-driven study and shares the key findings.

92. Understanding The Potential Of AI Med Devices Amid Regulatory Challenges 7/9/2024

    As AI medical devices continue to evolve, collaborating with regulatory experts and embracing multidisciplinary approaches are crucial for navigating challenges and ensuring regulatory compliance.

93. Adaptive AI-Driven Medical Devices In The US: Regulatory Guidelines 7/8/2024

    This article delves in what is considered an adaptive AI-driven medical device and the current FDA regulatory considerations for them.

94. Is Mexico A Prime Location For Medical Device Clinical Trials? 6/27/2024

    Mexico, one of Latin America's largest economies and most populous countries, is emerging as a prime destination for medical device clinical trials and other advanced medical technologies.

95. System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks 6/26/2024

    Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.

96. 8 Best Practices For Securing Investment In Diagnostics 6/25/2024

    To attract and secure investments in today's landscape, medtech and diagnostic companies should consider adopting these 8 strategies to highlight value and potential for growth.

97. The Growing U.S. Market For Endoscopic Gastrointestinal Devices 6/21/2024

    Ongoing technological advancements have made gastrointestinal endoscopes smaller and more efficient. This article looks at the growing U.S. market for such devices.

98. Medical Device Assembling And Packaging: Should You Outsource? 6/18/2024

    Medical device assembly and packaging are often afterthoughts, but they are critical decisions. Consider these crucial factors to make the right decision for your device and your company.

99. Long Live Design Controls, Part II: A Systems Engineering Perspective In The QMSR Paradigm 6/6/2024

    The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (QMSR), risk management can be integrated with the design control process.

100. Balancing Sustainability With Patient Safety In Medical Device Design 6/3/2024

     There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives.