Determined to satisfy its customers' needs, the company spared no effort to achieve ever-increasing reliability. Modern machining techniques and stringent controls at every phase of manufacture and assembly held the key to products of impeccable quality. These were placed on the market by an international distribution network. Supported by highly qualified personnel, the management applied this rigorous policy to all its services. The results were soon apparent. Bien-Air Surgery SA is certified compliant with ISO 13485 standard, EEC directive 93/42 and gained FDA clearance.
These devices and their accessories are certified as a medical device in the European Union under the Medical Device Directive 93/42/EEC by SGS CE1639, exclusively for the indication(s) detailed into the corresponding IFUs. Other non-medical uses ascribed to these devices are not within the scope of CE certification, and users should be aware device performance and/or safety has not been evaluated by SGS for those purpose.
CE CertificateISO 13485 Certificate