Risk Management talk

Tang (first row, sixth from right) with the students

The Department of Mechatronics and Biomedical Engineering (DMBE) and Centre for Healthcare Science and Technology (CHST) of Lee Kong Chian Faculty of Engineering and Science (LKC FES) in collaboration with Johnson Medical International Sdn Bhd organised a talk titled “Managing risks at healthcare facilities-a supplier’s perspective” at Sungai Long Campus on 17 July 2017.

Present at the talk was Johnson Medical International Sdn Bhd Senior QA Manager Tang Keng Yuen, LKC FES Department of Mechatronics and BioMedical Engineering Head Dr Kwan Ban Hoe, Dr Tee Yee Kai, Dr Loo Joo Ling, Tan Yin Qing, and students.

In the talk, Tang spoke about the definition of risk management and the need to manage risk. He also mentioned about the importance of managing risks for medical devices at the pre-market stage (manufacturing) until the post market stage (usage). Apart from that, topics such as managing risks associated with the clinical waste management services, managing risk through maintenance of hospital facility, risk assessment, post-delivery of medical device at the customers' site; relevant standards and regulatory requirements were presented by Tang.

He also mentioned some regulations and standards which were applicable for medical devices such as Medical Device Act 2012, (737), Medical Devices regulation 2012, Medical Device Directives (MDD) 93/42/EEC, ISO 13485, ISO 14971, IEC 60601-1 and ISO 9170-1. Further to his talk, he gave an overview on the concerns of indoor air quality and the importance of maintaining good indoor air quality.

“In my opinion, the Malaysian government realise how important it is to regulate the medical devices in Malaysia to avoid possible disastrous outcome due to the increase in sickness and aging population. The health sector industry is growing therefore Malaysia needs engineers with expertise in medical devices. We also need more engineering students to be exposed and trained in such area from the product designing until the retail stage in order to stay relevant in the industry,” said Tang.

Dr Kwan (second from left) presenting the token of appreciation to Tang (second from right) while Dr Loo (left) and Dr Tee (right) look on

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