Our ISO 13485 Consultation helps organisations in the medical device industry develop, implement, and maintain a robust Quality Management System (QMS) in line with international standards. This service is designed for companies seeking regulatory compliance, certification readiness, and improved product quality and safety.
This consultation is suitable for organisations across medical device manufacturers, suppliers, distributors, and OEMs, supporting risk-based quality management, regulatory compliance, and audit readiness.
Quality Management System Development – Establishing a QMS aligned with ISO 13485 requirements
Regulatory Compliance & Risk Management – Ensuring compliance with medical device regulations and risk-based processes
Process Approach & Product Lifecycle Control – Controlling design, production, and post-market activities
Monitoring & Reporting – Preparing audit-ready documentation, records, and performance metrics
Internal Audit & Continual Improvement – Conducting audits, corrective actions, and quality improvement initiatives
Ensures compliance with ISO 13485 and medical device regulations
Improves product quality, consistency, and patient safety
Supports regulatory approvals and market access
Enhances operational efficiency and process control
Strengthens stakeholder confidence and supplier credibility
Provides audit-ready documentation for certification bodies
Identifies quality improvement opportunities and corrective actions
Integrates with ISO 9001 for a unified management system
Our consultancy covers full ISO 13485 implementation and certification preparation, including:
Gap analysis and readiness assessment for ISO 13485
Development of quality policy, objectives, procedures, and SOPs
Risk management planning and implementation
Design and development process controls
Supplier and production process management
Internal audit planning, execution, and corrective action management
Monitoring, measurement, and performance evaluation
Management review facilitation
Pre-certification audit preparation and Certification Body coordination
Medical device manufacturers and OEMs
Component and raw material suppliers for medical devices
Distributors and contract manufacturers
Companies preparing for ISO 13485 certification or regulatory compliance
Organisations aiming to strengthen quality management and patient safety
We provide a hands-on, step-by-step ISO 13485 consultancy focused on practical quality system implementation, regulatory compliance, and certification readiness, not just documentation. Our approach is customised to your medical device operations, product range, and regulatory requirements, ensuring your QMS is effective, compliant, and audit-ready. We guide your team to confidently understand, implement, and maintain ISO 13485 requirements for long-term quality and safety performance.
More detail about CAYS GROUP PLT
Malaysia
