| Over 60 members and guests attended the AMMI Global Expert Sharing Session on EU Medical Device Regulations at E&O Hotel Penang on 1 November 2017. The objective of this event is to provide insight and facilitate discussion among AMMI Members and key stakeholders on the impact of the new Medical Device Regulations in Europe for the Medical Device Industry. The event started off with the Key Note Presentation on “Challenges and Expectations of the New Medical Device Regulations in Europe for the Medical Device Industry” by Mr Juergen Heil, Senior Vice President Quality & Environment Management, B. Braun Melsungen AG, Germany, This was followed by a Panel Discussion led by Mr Frank Ried, Director of Ried Q&C Consultancy. The distinguished panel members also included Mr Juergen Heil, Peter Porzler, Vice President, Medical & Health Service (MHS), Global Non-Active Medical Devices, TUV SUD and Mr Tony Low, Director of Quality Assurance & Regulatory Compliance, Commissioning Agents International . |
| Watch the video highlights here… |
| From left to right : Mr H.T. Eow (AMMI Secretary-General/ Managing Director of Abbott, Mr Juergen Heil, Mr Frank Ried, Mr Peter Porzler, Mr Tony Low and Mr CS Ching (AMMI Executive Director). |
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| Members and guests signing in…. |
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| Refreshments and networking before the start of the session… |
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| Welcome Remarks by Mr HT Eow (AMMI Secretary-General / Managing Director of Abbott) |
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| Keynote Presentation on“Challenges and Expectations of the New Medical Device Regulations in Europe for the Medical Device Industry” by Mr Juergen Heil. |
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| Panel Discussion led by Mr Frank Ried together with Mr Juergen Heil, Mr Peter Porzler and Mr Tony Low |
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| Mr HT Eow presenting tokens of appreciation to Mr Juergen Heil, Mr Peter Porzler, Mr Frank Ried and Mr Tony Low. |
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| Mr CS Ching updated guests on upcoming AMMI events and training programme before wrapping up the session. It was indeed a very fruitful evening, with a very comprehensive sharing session from the global experts. |
7 Sept 2017: AMMI Q3 Progress Meeting and Networking Cocktails
AMMI held its Q3 Progress Meeting at The Gardens Hotel Midvalley on 7 September 2017. This was followed by a World Cafe Workshop style session, with AMMI members discussing two major topics – (1) Challenges of the proposed Draft Malaysian Standard – Halal Medical Device and (2) Strategic Approach to Local Market Access (facilitated by Economic Planning Unit).
After the World Cafe Workshop group discussion sessions, representatives from the two groups gave a summarised presentation on the feedback and views from members. .
After the meeting, members and guests adjourned to Ri Yakitori for networking cocktails.
13-14 Sept 2017 : Medical Device Manufacturing Process Validation, KL
| AMMI organised the training on Medical Device Process Validation Training at Dorsett Grand Subang (13-14 Sept 2017). Thirty (30) participants from eleven (11) companies attended the training which was conducted by industry expert, Mr Gobu Devarajan. The course provided regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA’s Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. |
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| Class in Session… |
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| Participants were divided into groups during the Workshop Session. |
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29 August 2017 : AMMI CEO Evening Talk on Industry 4.0 for the Medical Device Industry
| AMMI held its first CEO Evening Talk on Industry 4.0 for the Medical Device Industry at the Equatorial Hotel Penang . The objective of this event is to provide insight and updates, as well as facilitate open discussion among top management level representatives of AMMI Member Companies and key stakeholders on the impending age of Industry 4.0 in the Medical Device Industry. Forty-five members and guests attended the event, which started with a welcome speech by AMMi Chairman, Mr Hitendra Joshi. Dr Juergen Schloesser, Vice President, Operations & Head, Centre of Excellence, Intravenous-Access, B. Braun Medical Industries Sdn Bhd. gave a presentation on Industry 4.0 for the Medical Device Industry . This was followed by a Panel Discussion led by Mr Martin Tonko from Roland Berger. Panel members include Dr Juergen Schloesser, Mr YJ.Lim, Regional President , Plexus APAC, Mr Michel Van Crombrugge, Country Manager, Paramit Malaysia Sdn Bhd and Mr Dave Mitchell, VP Operations, Boston Scientific Medical Device (Malaysia) Sdn Bhd |
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| After the talk, guests adjourned for networking cocktails at the Ballroom foyer. |
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30-31 Oct 2017: AMMI Training on 21 CFR Part 820
| AMMI organised a training on 21 CFR Part 820 at the E&O Hotel from 30-31 October 2017. Seventeen (17) participants from seven (7) companies attended the training. The training was conducted by industry expert, Mr Frank Ried and provided participants with an overview of the FDA and intention of the 21 CFR Part 820. It also covered current requirements of the 21 CFR Part 820, working knowledge in application to their organization as well as ability to prepare and host an FDA inspection. |
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