Company is among the first in China's drug-device combination products sector to obtain this certification, delivering superior solutions to global clientsZero non-conformities demonstrates company's ...

The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which ...

The medical technology industry has gone through some changes in the last 14 years, as has its regulatory environment, and it was time that ISO 13485 reflected that evolution. The global standard for ...

An overview of ISO 25500 and the importance of compliance with this standard to support AI adoption in supply chain ...

Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for ...