Author Archives: Melissa

Over 50 members attended the AMMI 30th Annual General Meeting and Q2 Meeting held at E&O Hotel Penang. The AGM saw the retirement of AMMI Secretary-General, Mr H.T Eow (Abbott).

The AMMI Executive Board was announced during the meeting, with the following line-up:  Chairman – Mr Christophe Marque (Stereo), Vice-Chairman, Mr John Ward (Steripack) , Vice-Chairman , Mr Andy Lee (Johnson & Johnson), Secretary-General, Dato’ Dr Haminnuddin (Ideal Healthcare) and Treasurer, Mr Michel Van Crombrugge (Paramit).  The  following member representatives were also elected to the AMMI Board of Directors:  Dr Yuma Konishi (Texchem), Mr Samuel Pooranakaran (Cochlear), Mr Dave Mitchell (Boston Scientific) and Mr André Holzhausen (B.Braun Medical Industries)

Members then proceeded with the Q2 Progress meeting, followed by a briefing on the New NCER Tax Incentives and NCER Talent Enhancement Programme (NTEP) by Mr Jaspher Loo from the Northern Corridor Implementation Authority (NCIA).  After the meeting, guests adjourned for CEO Networking after the meeting.

Forty-four participants from thirteen companies attended the AMMI Global Expert Training on Medical Device Usability held at G Hotel Kelawai, Penang. The one-day seminar was conducted by global expert, Mr Merrick F Kossack – who specialises in applying human factors to the design and development of medical devices.

Sixty six participants from 21 companies attended the AMMI Global Expert Training on Medical Device Packaging held at E&O Hotel, Penang. The one-day seminar was conducted by global expert, Mr Dan Floyd from DuPont and focused on Sterile Medical Packaging Regulatory and Standards Review, changes after implementation of new Packaging Standards as well as various Medical Devices Sterilization techniques.

Eighteen participants attended the AMMI Industry Expert Training on ISo13485:2016 Quality Management Systems, held at Hilton Petaling Jaya on 20-21 March 2019. The course, conducted by Mr Tony Low, introduces the concepts needed to understand, develop/upgrade, and deploy a quality management system as outlined in the medical devices  quality management standard ISO 13485:2016. The course also covered aspects of ISO 14971, which contains key principles and guidance for risk management.

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.