Artificial Intelligence Graphic
Artificial Intelligence Graphic

Demystifying Regulatory Hurdles: How to Navigate FDA Approval for AI-Enabled Medical Devices

By Cory Hayes, Jeanna Blitz

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s specific requirements. An appreciation of the unique considerations for artificial intelligence-enabled technologies is another essential component of an efficient and effective application.

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Dhirti Roy
Dhirti Roy

Ask the Expert: What is Regulatory Excellence in the Medical Technology World?

By MTI Marketing Staff

Regulatory excellence is now considered a pathway to innovation and sustained business growth, making it a fundamental component of success in the medical devices industry. MedTech manufacturers are fostering a culture of regulatory excellence to enhance compliance with regulatory requirements and ensure product safety, efficacy, and quality in the global marketplace.

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Dr. Xiaoxia Li
Dr. Xiaoxia Li

From Concept to Market: The Strategic Journey from IND to NDA

By Dr. Xiaoxia Li

The Investigational New Drug (IND) application and the New Drug Application (NDA) stages are critical milestones in drug development, but they are different applications. Developers and sponsors must understand which application requires which data and when. Here we highlight strategies, hurdles and data required for successful drug development from IND to NDA.

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Nick Recht
Nick Recht

IQ OQ PQ and Its Role in Labeling System Validation

By Nick Recht

Software validation is a critical tool used to assure the quality of device software and software automated operations, including labeling. Software validation can increase the usability and reliability of the device and label, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.

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Philip Remedios 2023
Philip Remedios 2023

Navigating the New Normal: Achieving R&D Success in Hybrid Work Environments

By Philip Remedios, Renée Bailey

Implementing a hybrid work environment with R&D teams yields significant benefits but also presents challenges. In this article, we explore how to achieve successful R&D programs within the context of hybrid environments and share key strategies and best practices to effectively navigate the challenges, including the safeguarding of sensitive information and data.

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