Home
Contact
About us
Qualifications
Project Management
Risk Management
Pharma risk management
Medical Device Risk Mgt
Consulting
Training
Speaking engagements
Forensic Document Examination


Although ISO 14971:2007 is required only by the Japanese regulatory agency, medical device companies follow the international standard for product quality risk management. The FDA requires medical device companies to perform risk assessment. Risk assessment is a portion of risk management.

The model of risk management from ISO 14971 is presented with modifications. The dashed line between "Evaluation of overall residual risk acceptability" and Risk Control is described in the text of the stand yet is missing from the drawing in the standard. The risk policy and risk plan are described as required deliverables in the standard yet are missing from the diagram.

The model on this page represents a more complete picture of the ISO 14971:2007 with the 2009 correction.

New paragraph

Top