| AMMI-Medsociate organised the training on Risk Management for Medical Devices ( EN ISO 14971 : 2012 ) on 5-6 October 2016 at G Hotel Gurney in Penang. Twenty seven (27) participants from twelve (12) companies attended the training, which was conducted by industry expert, Ms PS Gan. This training aimed to provide participants with a clear understanding and insight into the ISO 14971 – application of risk management to medical devices and identify the hazards associated with medical devices and their accessories, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control. |
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ISO13485 Internal Auditing Training, 21-22 April 2016
| AMMI-Medsociate organised its Industry Expert Series Training Course on ISO13485 Internal Auditing at Majestic Hotel, Kuala Lumpur from 21-22 April 2016. 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, taking into account the new ISO13485 : 2016. Apart from the very interesting workshop and training, participants also enjoyed sumptuous buffet lunch at Contango Restaurant and delicious tea-breaks at the Majestic. |
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MTEP Batch 2 Completion Ceremony, 12 April 2016
| The AMMI-NCIA Medtech Talent and Employment Programme concluded with the Completion Ceremony for the final batch of graduate trainees at Sunway Hotel on 12 April 2016 . It was indeed a proud moment for the graduate trainees from Batch 2 when they received their certificates from Mr Michael Raja, Manager of Education & Human Capital Development, of Northern Implementation Corridor Authority (NCIA). The event was also graced by Mr Hitendra Joshi, Chairman, Association of Malaysian Medical Industries (AMMI) , Mr KK Yap (AMMI Director & Leader of Talent Development Committee ), Cik Azhana Binti Mohamed Saleh (Director, MIDA Penang), Encik Abdul Mukti bin Abu Bakar (Director, MIDA Kedah & Perlis ) and Puan Nor Asmahan Othman (Industry Partnership, Talent Corp) as well as HR Representatives from participating companies. |
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| ABio Orthopaedics Sdn Bhd |
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| B.Braun Medical Industries |
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| Epsilon Medical Sdn Bhd |
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| Haemonetics Malaysia Sdn Bhd |
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| Penchem Medical Sdn Bhd |
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| Teleflex Sdn Bhd |
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| Synergy Health (now part of Steris) |
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| UWC Healthcare Mfg Sdn Bhd |
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1-2 June 2016 Process Validation Training
| AMMI-Medsociate organised its Industry Expert Series Training Course on Medical Device Manufacturing Process Validation at E&O Hotel Penang from 1-2 June 2016. The 2-day course was designed to
provide 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 programme. |
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20-21 July 2016 : Transition to ISO13485 : 2016 QMS
| AMMI-Medsociate organised its industry expert series training on Transition to ISO13485 : 2016 Quality Management System on 21-22 July at E&O Hotel Penang. Over 40 participants attended the course.
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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