Under ISO 13485, more comprehensive design planning, including the use of risk analysis and increased design input and output considerations, is required.
Companies in this article
Amcor receives ISO 13485 certification
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
Recommended
Recommended
The building envelope is a production asset
Condensation, energy loss, and sanitation failures often trace back to the same place. This free article shows where to look.
Read More
Downloads
