is being presented by Phil Triolo, President, of Phil Triolo and Associates LC and airs on Tuesday, March 22nd, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Clinical Evaluation Reports (CERs) document the assessment and analysis of clinical data (literature, results of clinical investigations, complaints) and preclinical data to establish conformity of a medical device with the pertinent requirements of the Medical Devices Directive.
Recent publication of ISO 14155:2011 introduces new requirements that supplement the requirements and recommendations for CERs that appear in MEDDEV 2.7.1 Rev 3 and GHTF document SG5/N2R8:2007.
This audio conference presentation outlines these new requirements and provides helpful hints and examples of how to meet, efficiently and effectively, new and existing CER requirements.
