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Certifications

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Certifications2022-04-25T15:17:21+00:00

Our manufacturing and distribution facilities are designed and managed to meet the highest standards of quality control. Our manufacturing facility meets all of the recognized international standards including ISO 13485:2016 CMCDCAS, FDA GMP, Health Canada and the CE standards

We are committed to providing the highest quality product possible and to continually improving our designs and manufacturing processes. You can be confident when you purchase Flight dental equipment, that you are purchasing the very best.

ELT Mark

The ETL Listed Mark is proof of product compliance (electrical, gas, and other safety standards) to North American safety standards, including UL, ANSI, CSA, ASTM and NFPA standards.

FDA 510K Premarket Authorization

This authorization relies on the use of guidance documents, special controls, and recognized standards. FDA is authorized to recognize all of part of national and international consensus standards through publication of a notice in the Federal Register. Recognized standards could be cited in guidance documents or individual policy statements, or established as special controls that address specific risks associated with a type of device.

ISO 13485:2016

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices.

Health Canada Device License

Health Canada is the federal regulator of therapeutic products, including medical devices. The Medical Devices Bureau (Bureau) of the Therapeutic Products Directorate, Health Canada is the Canadian federal regulator responsible for licensing medical devices in accordance with the Food and Drugs Act and Regulations and the Medical Devices Regulations.

Health Canada MCE – Export

A Manufacturer’s Certificate to Cover Export of Medical Devices is issued for medical devices that are legally for sale in Canada, which are intended for export to a foreign country and are currently licensed for use in Canada.

Questions? We have answers…

If you have any questions regarding our certificates or need more information, please use the following form to contact us and one of our professional team will get back to as soon as possible.

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