Medical device manufacturers are adopting integrated quality management systems that extend past compliance to drive cost ...

On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR. The QMSR ...

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice regulations with the international ISO 13485 standard, Medical ...

The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments. FDA ...

The Asian economy has experienced tremendous gross domestic product (GDP) growth over the past decade and is expected to continue at a healthy pace for the next several years. The medical device ...

Just 27% of 230 medical device makers surveyed expect to be in full compliance with the European Union’s Medical Device Regulation (MDR), which goes into effect in May next year, a study has found.

Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this ...

Language Scientific has provided a practical overview of IFU translation requirements for medical device documentation, emphasizing how clear and accurate Instructions for Use support patient safety, ...

Agile PLM supports continuous improvement, enhances visibility across the product lifecycle, and reduces the risk of costly errors. As a result, it is becoming a cornerstone of modern medical device ...

Quality control is often still a manual process, particularly in medical device manufacturing. Vision inspection technology can help automate inspection, but manufacturers still face challenges.

City, India, December 23, 2024: In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device manufacturers are enhancing their Good ...