TEE Probe Repairs

Probe repairs and the materials used in the repair process are validated against all published OEM specifications. In the absence of published specifications Acertara’s engineering and ultrasound physics lab measures and tests essential performance parameters and validates both the repair process and materials used to ensure substantial equivalence as defined by the FDA’s 2017 510(k) Ultrasound Guidance Document; Sections 5.1.2.8, 5.2.2.1.1, 5.2.3.2, and Appendix C

ISO17025:2017 Accredited Acoustic Testing and Calibration Lab

Probe Repair Certified to ISO13485:2016

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