Surveys indicate that the number of vendors and suppliers that seek to obtain risk management compliance certifications is growing. The trend may mean good news for OEMs.

Medical Device & Diagnostic Industry - May, 2007

Two important standards define the quality systems used in the medical device industry: ISO 13485:2003 and ISO 14971:2000 (up for revision in 2007). These standards specify the important requirements for process and software validation, as well as risk management.

First, Do No Harm

In the Hippocratic oath to “First, do no harm,” risk management forms a fundamental basis for decision making in a medical context. The benefits of a risk-based approach to quality systems are significant. These benefits are the primary reason that the concept was documented in ISO 14971 and formally introduced to medical device quality systems via ISO 13485. Read More

—Marc Miller, Crimson Medical Translation