This 1-day intensive in-house course provides key messages that are needed to obtain value from your organisation’s implementation of ISO 13485:2016 in compliance with applicable regional regulatory requirements. Either directly or indirectly, ISO 13485:2016 will have profound effect on the medical devices industry in this decade. In today’s medical supplies industry, the criteria of safe and effective medical devices are the key factors towards the consistency a quality management system in meeting the customer expectations as the basis for setting of strategy and objectives, the improvement of processes worldwide, and the measurement and overall improvement in strategic areas are essential to an organisation’s survival and in compliance with statutory and legal requirements.
The "hands-on" program includes lectures, workshops and a case study to increase participant knowledge and learning. This course is also available for in-house presentation with or without the ISO 13485:2016 standard. This training course may be used in its original presentation format or it may be customised by referring to the degree of business nature.
Date: 8th March 2024
Venue: Supercomal Medical Products Sdn. Bhd., Sungai Petani, Kedah
Course Objectives:
This course is designed to provide participants with the awareness of the ISO 13485:2016 throughout the product life cycle of a medical device, and its interface with the Malaysian Act 737 and its regulations. Having completed this course, participants will understand the ISO 13485:2016 requirements; and the interface between ISO 13485:2016 with the Malaysian Act 737 and its regulations.
Who Should Attend:
Directors, Managers, Internal Auditors, and Key staffs.
More Training Pictures:
Feel free to contact TSY Consultancy by Call / WhatsApp to +6012-6243921 or email to marketing@tsy.my
Cheers.
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