Medical Devices

Course Objective

• Understanding of the ISO 13485 foundation
• Understanding of the roles of the top management in the ISO 13485 QMS
• Understanding the requirements of the ISO 13485 that is relevant to top management

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

GDPMD is the Regulatory requirements for Medical Device Safety & Performance. In the Medical Devices Regulation 2012, Appendix 4 – Requirements on the Quality Management System, it specifies that Authorized Representative, Importer and Distributor is required to certify under GDPMD.

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:

• Overview of the FDA and intention of the 21 CFR Part 820 Quality System Regulation (QSR)
• To understand the up-to-date requirements of 21 CFR Part 820 QSR and other Parts such as Part 11, Part 803 and Part 821
• Working knowledge in application of the requirements
• Preparation for FDA

Course Objective:

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

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:

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

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.

Course Objective:

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