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ISO 13485:2016 Training and Consultation

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25TH – 28TH SEPTEMBER 2017

Kubang Kerian – September 25th 2017,  the 1st Training and Consultation sessions for ISO 13485:2016 were organized by In-Vitro Diagnostics (IVD) Unit, INFORMM Kelantan. The sessions were conducted by experienced instructor, Dr. Loi Kheng Min from KM Loi & Associates Sdn. Bhd. The 4-days intensive course was aimed to enhance skills and  competencies, mainly to all members of IVD Unit, INFORMM. The training session was modulated to give a good and effective understanding of all requirements and regulations differences between ISO 13485 standards version 2003 and 2016. Understanding of the ISO 13485:2016 standard is important in order to begin implementation or update an existing Quality Management System to comply with ISO 13485:2016. The consultancy session involved activities including discussion, brainstorming and also preparing as well as reviewingdocumentations towards the design, development and production of in-vitro diagnostic (IVD) medical devices.   

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