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The medical device industry is evolving with AI and automation affecting production and quality management. Quality engineers are moving towards systems thinking and proactive decision-making, as AI becomes integral to production, presenting challenges and opportunities for innovation while ensuring safety.

This article explains how a Quality leader can establish external requirements by defining products in a specific region, using medical devices as an example based on FDA regulation Section 201(h) and the 513g Request process. Following this prevents wasting time, funds, and resources on incorrect regulatory assumptions.

Industries like aerospace and automotive now require stringent quality assurance, focusing on proactive measures throughout the product lifecycle to ensure safety and continuous improvement.

Atty Chakraborty, our 2025 Quality Rookie of the Year, discusses her work in the emerging field of AI in the medical industry, including examples, predictions for the future, and how it may apply in your work.

In 2025, medical device manufacturers are grappling with heightened regulatory uncertainty, leading to slower reviews and communication difficulties with the FDA. This situation drives them to reassess operations for compliance and risk management, with a strong emphasis on maintaining product quality, which is vital for patient safety.

Meet our 2025 Quality Rookie of the Year, Attrayee Chakraborty. She is a quality professional in the medical field with a background in biotechnology and expertise in Artificial Intelligence (AI).

Quality is honored to name Attrayee Chakraborty as our 2025 Quality Rookie of the Year. Discover how she earned the award through her groundbreaking work in medical device quality and AI integration.

The life sciences sector is at a crossroads as the FDA updates quality management standards. AI is now expected, and the FDA's January 2025 draft guidance outlines its evaluation and implementation. Successful adoption depends on three key questions.

Quality interviewed the CEO of Spectrum Custom Packaging, our 2025 Plant of the Year, on how to train, maintain high quality, and find the right software.

RGB-IR camera technology simultaneously captures standard color (RGB) and infrared (IR) light using a specialized filter. This integration enhances medical imaging by providing improved diagnostic capabilities through dual-spectrum capture.