Aaron Troschinetz is the general manager at Smithers Quality Assessments (SQA, Akron, OH) where he oversees the operations of all Quality Management System programs. For more information, visit www.smithersregistrar.com
In 2017, much of the ISO standards user community, as well as the supporting third party certification industry, was left with the same question. What standards/specifications aren’t changing right now?
The standard known as ISO 13485: 2003 - Medical devices - quality management systems - Requirements for regulatory purposes, has become the global standard for those involved in the manufacture of medical devices.
