Our ISO 13485 Awareness and Internal Audit Training is designed for organizations in Malaysia’s medical device, healthcare, and biotech sectors, including manufacturers, distributors, OEMs, and SMEs. This program helps organizations build a solid understanding of medical device quality management requirements while developing internal capability to monitor, audit, and continuously improve their Medical Devices Quality Management System (QMS).
This training supports organizations preparing for ISO 13485 certification, improving product quality, ensuring regulatory compliance, meeting customer requirements, and enhancing operational efficiency in the medical device industry.
The ISO 13485 Awareness Training builds a clear understanding of medical device QMS principles, regulatory requirements, and risk-based approaches.
Participants will learn:
Overview and structure of ISO 13485 Medical Device Quality Management System
Roles and responsibilities of top management and quality teams
Regulatory requirements (MDA, MOH Malaysia, FDA, EU MDR)
Risk management for medical devices
Product realization, design control, and process validation
Corrective and preventive actions (CAPA) and non-conformity management
Documentation, records, and common ISO 13485 non-conformities
The ISO 13485 Internal Audit Training focuses on developing effective internal auditing skills for medical device QMS.
Participants will learn:
Purpose and planning of ISO 13485 internal audits
Internal auditor roles, independence, and audit techniques
Preparing QMS audit programs, checklists, and audit reports
Auditing design control, production processes, supplier management, and CAPA
Identification and reporting of non-conformities
Follow-up and verification of corrective actions
Alignment with ISO 13485 requirements and medical device best practices
Suitable for:
ISO 13485 / Medical Device QMS Team Members
Quality Managers & QA/QC Personnel
Regulatory Affairs & Compliance Officers
Production Supervisors & Managers
Risk Management & Internal Audit Personnel
Senior Management & Department Heads
Organizations preparing for ISO 13485 certification in Malaysia
Improve medical device QMS compliance and audit readiness
Reduce quality non-conformities and regulatory risks
Enhance internal audit effectiveness
Strengthen product quality, safety, and patient compliance
Build strong awareness and accountability among staff
Participants will receive a Certificate of Attendance for ISO 13485 Awareness & Internal Audit Training.
Malaysia-focused, regulation-aligned content
Covers MOH, MDA, FDA, and EU MDR requirements
Conducted by experienced medical device QMS and audit trainers
Practical, scenario-driven, and process-focused learning approach
Available as in-house or public training
Malaysia
