Our services cover the entire lifecycle of medical devices, ensuring compliance, safety, and performance from initial design to post-market activities.
Support during the product design and development phase, including regulatory planning, risk management, and technical documentation to ensure compliance from the early stages.
Comprehensive testing and validation services to verify that medical devices meet applicable technical, safety, and performance requirements before market entry.
Conformity assessment and certification services to ensure compliance with international regulations and standards, enabling successful market access.
Professional installation and commissioning services to ensure that medical devices are properly set up, tested, and ready for safe and effective operation.
Ongoing maintenance and calibration services to ensure continued accuracy, reliability, and compliance of medical devices throughout their operational lifecycle.
Monitoring and evaluation of device performance after market release, including data collection, analysis, and reporting to ensure ongoing safety and regulatory compliance.
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