The ISO 13485:2016 training course presents a key market opportunity for medical device organizations to enhance their quality management systems, ensuring compliance with industry and regulatory ...

The Food and Drug Administration (FDA) issued a Final Rule to amend device current good manufacturing practices (CGMP) requirements of the Quality System (QS) regulation to harmonize the requirements ...

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 ...

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 ...

Amend Surgical, a medical device company focused on novel products for oral wound-care and regenerative biomaterials, today announced that it has achieved ISO 13485:2016 certification, the global ...

This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...

This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...

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 ...

Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed ...

The three-year transition period of ISO 13485:2016 officially comes to an end this month, but that deadline is almost meaningless at this stage. If you’re a medical device OEM doing business ...