ISO 13485: 2016 Medical Devices

• Regulatory officers
• Quality managers
• Management Representatives
• Professionals tasked with overseeing a management system meeting ISO 13485 standards
• Medical device companies looking to set up their QMS and get ISO 13485:2016 certified

1. Introduction to ISO 13485 Medical Devices Quality Management System [MDQMS]

• Standards & Regulatory Frameworks
• Principles of QMS
• Key Quality Concepts
• ISO13485 Clauses 4 to 8.

2. Initiation of & Planning for the Implementation of MDQMS [PLAN].
3. Implementation of MDQMS [DO]
4. Monitor, Measure & Analyse Data [CHECK]
5. Continually Improve MDQMS processes [ACT]

• Learn how to implement a Quality Management System within your organization to enables better response to customer requirements and market changes.
• Learn how to transition your organization to meet the new requirements of the ISO standard.
• Understand the conformance requirements associated with your stated Quality policy.
• Learn how to implement, maintain, and continually improve your organization’s QMS.

• Training course materials containing practical examples
• Lunch and Refreshments (for face to face training)
• Certificate