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.
Sdn. Bhd)
Zeito Plastic Components Sdn Bhd
www.dexcom.com
Oliver Healthcare Packaging
YB Liew Chin Tong
