Training, Medical Devices

Course Objective

• Understanding of the ISO 13485 foundation
• Understanding of the importance of ISO 13485 to an organization
• Understanding the requirements of the ISO 13485 that is relevant to shop floor employee

• Understanding what is medical devices
• Basic knowledge on the ISO 13485
• An interpretation of the ISO 13485 requirements

Course Objective

• Understanding what is medical devices
• Basic knowledge on the ISO 13485
• An interpretation of the ISO 13485 requirements

Course Objective:

• General requirements for risk management system
• Risk analysis process, Risk evaluation process, Risk control and Evaluation of overall residual risk process
• Step-by-step of Risk Management Process
• Development of Risk Management File

Course Objective:

• Understanding of the ISO 13485 Internal Audit requirements
• Understanding the audit principles
• Practical skills necessary to plan, conduct, report and close out an internal audit

Course Objective:

• Understanding the GDPMD requirements
• Awareness on the key elements to ensure medical device quality and safety along the supply chain.

Course Objective:

• Understanding of the GDPMD requirements
• Understanding the audit principles
• Plan, conduct, report and close out an internal audit

Course Objective:

• Understanding what is medical devices
• Understanding of the Malaysian Medical Devices Law