26-27 JULY 2017 : RISK MANAGEMENT FOR MEDICAL DEVICES (EN ISO 14971:2012)
AMMI-Medsociate organised the training on Risk Management for Medical Devices ( EN ISO 14971 : 2012 ) on 26-27 July 2017 at Dorsett Grand Subang. Twenty eight (28) participants from seventeen (17) companies attended the training, which was conducted by industry expert, Mr Harry Wong. This training aimed to provide participants with a clear understanding and insight into the EN ISO 14971:2012 requirements and the Annex Zs which add interpretation on shortcoming of ISO 14971:2007 for European Medical Device Directive and to list down additional work to be done by manufacturer to satisfy EU Law. The training will also cover practical knowledge on how to applying FMEA as one of the commonly use risk management tools.