Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it has received C$ 2.4 million in new equity capital from the ...

ISO 13485 is an internationally recognized standard for quality management systems, created by the International Organization for Standardization to ensure the safety and effectiveness of medical ...

Stratasys Direct facility in Tuscon, Arizona, achieves ISO 13485 certification, and is now formally recognized for safety and reliability.

The Company successfully completed Stage I and Stage II Assessments performed by the notified body, BSI, to verify it has established, and is maintaining, a quality management system that meets all ...

As of Dec. 2003, all four US manufacturing sites of Amcor Flexibles Healthcare are registered to ISO 13485, the quality system specific to medical devices. Jan 31, 2004 Under ISO 13485, more ...

The data show that it is possible to replace silicone implants in breast augmentation with alternatives offering improved safety and quality of life ... by additive manufacturing (3D-printing) under ...

Zentek's patented technology platform ZenGUARD™ is shown to have enhanced viral filtration efficiency for surgical masks and aims to do the same for HVAC (heating, ventilation, and air conditioning) ...

From being a promising yet underexplored approach in the 1990s, mRNA therapeutics have evolved dramatically. The discovery of ...