Definition

What is quality?



- Quality is all the properties and characteristics of a product or service, which give it the ability to satisfy requirements.

Hélioscopie adheres to the references:
- ISO 9001 (2000)
- ISO 13485 (2003 and 2004)
- 93/42/EEC (1993) Directive
- Regulation of medical instruments (Canada)
- Field of application:
Design, manufacture and marking of implants and their accessories for the treatment of obesity.

Our implants are produced in France, in Vienne (38) on our company site. This ensures complete control from design to marketing of our products.

93/42 EEC Directive concerning medical devices; Regulation of medical instruments (Canada)

 



Quality controls



The Quality Department carries out numerous quality controls which take place at each stage of manufacture of Hélioscopie products. The environment in which our implants are designed is totally controlled (hygiene, initial contamination), thus certifying optimum sterilisation.

Product
- 100% control
- Size control on sampling
- Destructive testing on sampling

Environment
- Surface and air Petri dish testing
- Particle control
- Initial contamination control
- Pyrogen testing
- Sterilisation control

Traceability
The methods put in place by HELIOSCOPIE for identification and traceability make it possible to know at any time where a medical device is and with what material or component it was manufactured.

Certification documents:



- 1037/9001/1 certificate
- 1037/13485/1 certificate
- 1037/13485/2 certificate
- CE certificate for the gastric band
- CE certificate for the implantable ports
- CE certificate for the intragastric balloon system and the extraction kit