ISO 13485:2016 Sec. 8.5.2 – Corrective Action Adverse Effect

Quoting ISO 13485:2016

“The organization shall document a procedure to define requirements for: e) verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device…”

Orcanos CAPA Corrective Action (CA) offers the ability to refer to each part of the above requirement and to manage each corrective action in respect to the Adverse Effect it may have on the device in terms of:

1. Regulatory Requirements
2. Safety
3. Performance