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15.6.2011 WMDO NEWS
ISO 14155:2011 On the Way to Harmonization
Should we or should we not start using ISO 14155:2011 Clinical investigation of medical devices for human subjects -- Good clinical practice? Harmonization is definitely going to happen sometime in the fall of 2011. The format of the Annex Z has been adapted to the new requirements of the European Commission and CEN will proceed with the application for harmonization soon.
However harmonization should not be the sole and unique reason to start using ISO 14155:2011 versus the 2003 version. Many European Competent Authorities encourage manufacturers to apply the new version as it is clearly a more complete guidance document and definitely more in line with the 2007/47 updated requirements of the Medical Device Directives.
So clinical professionals should not wait to get up to speed with the content of ISO 14155:2011 and implement these into their Clinical Quality Systems as soon as possible.
To help you with this, WMDO has developed a complete 7 course suite entitled: “ISO 14155: In Depth Review” which will get anybody quickly up to speed in under 4 hours.
For more information, click here: ISO 14155: In Depth Review
For non-clinical professionals, please see the condensed version here: ISO 14155:2011 A Summary Review
