Is your quality system risk management file up to date for your next audit assessment of ISO 14971? As of July 2012, EN ISO 14971: 2012 replaced EN ISO 14971:2009. The difference between the two standards is the new Annex Zs. This Annex describes the differences and deviation for the European Directives.

Your auditor will be reviewing your files to determine if your QMS meets the gaps between the standard and the European Directives 93/42/EEC. You will be evaluated regarding what actions have been undertaken to meet compliance and continue to have CE Marking applied.

The risk management file will be reviewed for the following actions:

• Have you as the manufacturer reduced risk as much as possible?
• Have you as the manufacturer conducted a risk benefit analysis for all risks?
• Have residual risks been reduced incorrectly (reduced by just using training or warnings within the Device IFU)?
• What actions have been used to design out risk?

If you need assistance with getting your files ready for compliance to ISO 14971:2012 then give Qualitas Compliance a call at (919) 964-0939 or visit our website at www.qualitascompliancellc.com.