ISO 13485:2016 MDQMS Awareness
Malaysia ISO Consultant
Overview
How do you meet medical device regulatory requirements and ensure product safety?
This is an interactive course to provide participants with knowledge of the requirements of ISO 13485:2016 Medical Devices Quality Management System. ISO 13485:2016 will have a 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 consistency. A quality management system that meets customer expectations as the basis for setting strategy and objectives, improving processes, and measuring overall improvement in strategic areas is essential to an organisation’s survival and compliance with statutory and legal requirements.
This training is designed to enable participants to implement ISO 13485:2016 by understanding the requirements cited in the standard, effectively implementing key processes, and contributing to the effectiveness of the management system and safe products.
What you will learn
- Understand the requirements and mechanism of ISO 13485:2016
- Create simple process mapping
- Identify key requirements of each clause cited in ISO 13485
- Implement key requirements of ISO 13485:2016 effectively
- Embrace the implementation as the company’s business management system
Who should attend
Quality Managers, RA Managers, Auditors of Medical Device, Executives & Senior Management, cross-functional team members of implementation project, suppliers to the organisation
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