COMMITMENT TO PRODUCT REGULATIONS
Because the products manufactured by Tecnilatex are medical devices, Council Directive 93/42/EEC on Medical Devices, as amended by Directive 2007/47/EC, is applicable and these products must comply with the essential requirements established in the directive.
The CE marking on the products, which indicates that they comply with the essential requirements of the directive, is certified by the British Standards Institution (BSI) for condoms and the Spanish Agency for Medicines and Medical Devices of the Ministry of Health for probe sleeves. The BSI carries out two audits per year and the Spanish Agency carries out one audit per year.
In both cases the audits involve reviewing the Quality Management System to ensure it complies with standards ISO 9001 and ISO 13485 and is therefore still valid. Product quality characteristics are also checked to ensure they comply with standard ISO 4074.
Continuous control of all manufacturing and control processes guarantees the product meets requirements so the following certificates can be obtained: