Equipment Management

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Ensuring the reliability, safety, and compliance of your equipment is crucial for producing high-quality medical devices. Our consultancy offers specialized Equipment Management Services to help you oversee and manage the maintenance, calibration, and validation of your equipment. We work with your suppliers to ensure all processes are completed on time and meet stringent regulatory standards.

Our Equipment Management Services Include:

• Calibration Oversight: We coordinate with your suppliers to ensure precise and timely calibration of your equipment. Our oversight ensures that calibration processes comply with industry standards and regulatory requirements, maintaining the accuracy and reliability of your equipment.

• Maintenance Coordination: We manage and schedule routine maintenance and repairs through your suppliers to keep your equipment in optimal condition. By overseeing these activities, we help you prevent equipment failures, minimize downtime, and extend the lifespan of your equipment.

• Validation Management: We perform the validation processes of your equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring they meet all operational and regulatory standards.

• Documentation and Traceability: We ensure all equipment management activities are thoroughly documented and traceable. This includes maintaining records of maintenance, calibration, and validation activities provided by your suppliers, creating a clear audit trail.

• Regulatory Compliance: Our services ensure your equipment management practices comply with all relevant industry standards and regulatory requirements, including ISO 13485, FDA, and EU MDR. We stay updated on regulatory changes to ensure ongoing compliance.

• Training and Support: We offer training programs for your staff on best practices for equipment management, equipping them with the knowledge and skills to effectively oversee and coordinate with suppliers.