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Quality Overview


Our Quality Management Systems are certified to ISO 13485 and ISO 9001, and allow us to achieve and maintain high levels of satisfaction for our products and continually improve the operation.

Additionally, as manufacturers of medical devices for the industry, our facilities are FDA registered and listed to comply with regulatory requirements.

Advanced Quality Planning

We use Advanced Product Quality Planning methodology to fulfill customer requirements.

To ensure customer confidence, we perform thorough Process Validations through the IQ, OQ and PQ stages following specific customer guidelines.