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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 AI is now expected, and the FDA's January 2025 draft guidance outlines its evaluation and implementation.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.

Kalpita Mehta is a combination products and medical device expert at a top U.S. generic manufacturer. She specializes in developing complex pharmaceutical products like COVID-19 testing kits.

Keeping defects low and reducing scrap is not an easy task. But Spectrum Custom Packaging made it happen. Meet Quality's 2025 Plant of the Year.

The medical device industry needs strict testing that meets evolving standards. Collaboration between manufacturers and standards committees ensures accurate and reliable testing solutions. Automation can standardize processes, tackle the shortage of qualified lab personnel, and enhance quality and efficiency.