Our GDPMD Consultation helps organisations in the medical device industry develop, implement, and maintain a compliant distribution management system in line with GDPMD requirements. This service is designed for companies seeking regulatory compliance, audit readiness, and improved distribution and supply chain management.
This consultation is suitable for organisations across medical device distributors, wholesalers, logistics providers, and OEM supply chains, supporting risk-based distribution practices, regulatory compliance, and audit preparedness.
Distribution Management System Development – Establishing a compliant system aligned with GDPMD requirements
Regulatory Compliance & Risk Management – Ensuring adherence to medical device regulations and safe distribution practices
Process Control & Traceability – Managing storage, transport, and handling to maintain product quality and traceability
Monitoring & Reporting – Preparing audit-ready documentation, records, and performance metrics
Internal Audit & Continual Improvement – Conducting audits, corrective actions, and distribution process improvements
Ensures compliance with GDPMD and Malaysian medical device regulations
Improves distribution process control and product integrity
Reduces regulatory and operational risks
Enhances operational efficiency and traceability
Strengthens stakeholder confidence and supply chain credibility
Provides audit-ready documentation for regulators and certification bodies
Identifies process improvement opportunities and corrective actions
Our consultancy covers full GDPMD implementation and audit preparation, including:
Gap analysis and readiness assessment for GDPMD compliance
Development of distribution policies, procedures, and SOPs
Risk management planning for storage, handling, and transport
Warehouse and logistics process controls
Supplier and distributor management
Internal audit planning, execution, and corrective action management
Monitoring, measurement, and performance evaluation
Management review facilitation
Pre-certification audit preparation and regulatory authority coordination
Medical device distributors and wholesalers
Logistics providers handling medical devices
OEM supply chain operators
Companies preparing for GDPMD certification or regulatory compliance
Organisations aiming to strengthen distribution management and product integrity
We provide a hands-on, step-by-step GDPMD consultancy focused on practical distribution system implementation, regulatory compliance, and audit readiness, not just documentation. Our approach is customised to your distribution operations, product types, and regulatory requirements, ensuring your GDPMD system is effective, compliant, and audit-ready. We guide your team to confidently understand, implement, and maintain GDPMD standards for long-term product safety and supply chain performance.
More detail about CAYS GROUP PLT
Malaysia
