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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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Workshop Session |
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9 March 2017 : AMMI Q1 Meeting and CEO Networking
| Nearly 60 members and guests from APACMed, Standards Malaysia, MATRADE, MIDA, MDA and MITI attended the AMMI Q1 Meeting which was held on 9 March 2017 at Hilton Hotel Petaling Jaya. The afternoon started off with Q1 Progress Meeting, followed by presentations from guest speakers. Mr Fredrik Nyberg, CEO of APAC Med gave a presentation on the Challenges and Opportunities for Medical Device Industry in the Asia Pacific Region. After that, Encik Ridzwan Kasim, Senior Director of Standards Malaysia briefed AMMI members on the new development of the Halal Standard for Medical Devices. and engaged members in the Q&A session. After the meeting guests adjourned to Uncle Chilli’s for networking cocktails. |
Meeting in session… |
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| AMMI Board of Directors (from left to right) : Dato’ Dr Haminnuddin Hj. Abdul Hamid, Mr John Ward, Mr Hitendra Joshi, Mr Christophe Marque, Mr Yap Kee Keong and Mr Chin Hock Meng, with guest speaker, Mr Fredrik Nyberg , CEO of APACMed. |
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CEO Networking at Uncle Chilli’s |
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5-6 April 2017 ISO 13485:2016 Quality Management System
| AMMI organised its industry expert series training on ISO13485 : 2016 Quality Management System on 5-6 April at Dorsett Grand Subang. Eighteen participants from 10 companies attended the course, conducted by Mr Tony Low. This course introduced 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; as well as discussed the aspects of ISO 14971, which contains key principles and guidance for risk management. |
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17-18 May 2017 : ISO13485:2016 Internal Auditing Training
| AMMI organised its industry expert series training on ISO13485 : 2016 Internal Auditing on 17-18 May 2017 at E&O Hotel Penang. Twenty participants from 10 companies attended the course, conducted by Mr Tony Low. The 2-day course was designed to give participants the knowledge and skills needed to undertake an unbiased and constructive ISO 13485 Quality Management System audit in line with the generic guidelines laid down in ISO 19011. Participants learnt he skills and techniques of a process audit and how to communicate the findings so as to increase the effectiveness of the organisation’s management system. |
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