MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...
In February 2026, the medical device industry will be faced with new regulatory challenges that could shake up operations. The good news? Companies that are already in compliance with existing FDA ...
Shanghai Kohope Medical Devices Co., Ltd., a leading syringe manufacturer and medical needle manufacturer, today announced a major expansion of its manufacturing operations with a 20% increase in ...
When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...
In recent years, pharmaceutical companies have broadened their horizons, moving beyond drug development to enter the medical device market. This strategic shift allows pharma to offer integrated ...
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