Endra Life Sciences Inc (NDRA)

[apollo1452]

"How long does Euro CE Marking certification take? On average, certification takes 6 to 8 weeks for a single product. This depends on the test results, whether the product still needs to be modified & how quickly the technical documentation can be supplied."

Remember, on 4/3/19 NDRA received Medical Device Quality Management System ISO 13485:2016 & EN ISO 13485:2016 certification, under Certificate Number MD 697226 from British Standards Institution (BSI).

This ISO certification indicates that the company's Quality Management System (QMS) meets the most current regulatory requirements specific to the medical device industry.

The ISO 13485:2016 standard for medical devices establishes the requirements for a comprehensive system, covering the design, development, control of manufacture, service, installation and distribution of the TAEUS FLIP System thermo-acoustic enhanced ultrasound medical devices and accessories.

Francois may be ahead of schedule thanks to the ISO certification...