| AMMI organised an Exclusive AMMI Senior Management Session recently at E&O Hotel Penang. The Breakfast Talk was by Ms Linda Chatwin , Esq, RAC, from UL. She spoke on the topic of GUDID Database of all Medical Devices, Digital Health and Cybersecurity issues. The session was attended by 20 participants from Abbott, B.Braun, Bemis, KLS Martin, Mediquip, Molnlycke, Sanmina SCI, Teleflex, Top Glove, UWC and invited guest from CREST. |
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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. |
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30 March 2017 : Networking Session in Johor Bahru
| The Association of Malaysian Medical Industries (AMMI) organised an Engagement and Networking Session with Captains of Medical Device Industry in Johor in collaboration with Malaysian Investment Development Authority (MIDA) recently at the Hotel Jen Puteri Harbour. The objectives of the proposed event are to engage relevant medical technology companies based in Johor and to foster closer collaboration between MIDA Life Sciences & Medical Technology Division and AMMI in spearheading the development of medical device manufacturing industry in Malaysia. |
| It was a fruitful session attended by top management of AccoBiotech Sdn Bhd, Aurum Healthcare Sdn Bhd, Bactiguard Malaysia Sdn Bhd, Ciba Vision Johor Sdn Bhd, Biocon Sdn Bhd and Kelpac Medical Asia Sdn Bhd ; as well as AMMI Members, Zeito Plastics Sdn Bhd and Stereo Sdn Bhd. Mr Hitendra Joshi, AMMI Chairman and Mr Ching Choon Siong, AMMI Executive Director represented AMMI, while the MIDA team was heded by Puan Balkish Md Yasin, Director of Life Sciences and Medical Technology. |
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4 May 2017 : AMMI RA Group Meeting & Dialogue with MDA
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AMMI organised its Regulatory Affairs Group Meeting, followed by an Exclusive Dialogue Session with Medical Device Authority (MDA) Chief Executive and Senior Officials on 4 May 2017 at Dorsett Putrajaya. The meeting was attended by 55 AMMI members and invited guests (from Medical Device Authority, MATRADE, MITI and Ministry of Health). |
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16 May 2017 : Workshop on FDA Design Control and Conducting FDA Style Mock Audit
| AMMI organised its Global Expert Training on FDA Design Control and Conducting FDA Style Mock Audit at E&O Hotel Penang on 16 May 2017. The workshop training was conducted by Ms Linda Chatwin, Esq, RAC, from UL. Eighty (80) participants from twenty four (24) organisations attended the workshop. |
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