Quality management system standards are a great tool for organizations wanting to plan an effective and efficient quality management system. ISO 13485, the ISO standard for medical device quality ...

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions to ...

This workshop will provide you with a concise but detailed review of the new ISO 13485 Medical Devices Quality Management System standard. We will compare the 2016 version to the 2003 version, and ...

YOKNEAM ILLIT, Israel--(BUSINESS WIRE)--ForSight Robotics, the pioneer in ophthalmic robotic surgery, announced today its achievement of ISO 13485:2016 certification, an international benchmark for ...

On Feb. 2, 2024, FDA published its long-awaited amendment to its current good manufacturing practice requirements for medical devices. The new Quality Management System Regulation (QMSR) now ...

To support medical device manufacture, Staffordshire EMS firm AWS has qualified its quality management system to ISO 13485:2016. The recently revised standard places greater emphasis on risk ...