17-18 April 2019: Risk Management Training

17-18 March 2019: Risk Management Training

Fifteen participants from twelve companies attended the AMMI Industry Training on Risk Management for Medical Devices held at Dorsett Grand Subang.  The two-day course was conducted by Mr Harry Wong, The training provided participants with a clear understanding and insight into the EN ISO 14971:2012 requirements and the Annex Zs which add interpretation on shortcomings of ISO 14971:2007 for European Medical Device Directive and listed down additional work to be done by manufacturer to satisfy the EU Law. The training also covered upcoming ISO 14971 and ISO/TR 24971 updates/revision and practical knowledge on applying FMEA as one of the commonly used risk management tools.