ISO 13485

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

ISO 13485:2016 Consultancy ISO 13485 Background

ISO 13485 specifies the requirements for a quality management system for medical devices. In the medical devices industry, organization have to comply with the customer requirement and most importantly, meeting the applicable regulatory requirements relevant to the specific medical devices.

• 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:

• 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:

• General requirements for Process Validation
• The linkage of the Process Validation with the standards and regulatory requirements
• Step-by-step on performing the Process Validation
• Hands on experience to develop Process Validation documentation

Course Objective:

• General requirements for Software Validation
• The linkage of the Software Validation with the standards and regulatory requirements
• Step-by-step on performing the Software Validation.<