The certifications obtained by our Company, represent an important commitment to the market, which began in 2004 with the certification of the Quality Management System according to ISO 9001-2000 (Certificate No. 04100 20041419 RWTÜV Systems GmbH) and subsequently completed through the development of an additional system of quality management according to ISO 13485-2012 defining for manufacturers of medical devices further guarantee that their products are designed, manufactured and marketed in accordance with the standards set out in the regulation, in order to meet the specific requirements of the market and the laws of reference.

The ISO 13485 is a standard that has an affinity with the concepts defined in ISO 9001, increasing the specific value for the medical field requiring special attention on the relevant requirements for the safety of medical devices placed on the market.

Our certificates:

• UNI EN ISO 9001:2015 Design, manufacturing of ultrasonic cleaning and thermo-disinfection equipment for medical and industrial sector and environmental analysis (Download Certificate Reg.N: 9319-A)
• UNI CEI EN ISO 13485:2016 Design, manufacturing of ultrasonic cleaning and thermo-disinfection equipment for medical sector.(Download Certificate Reg.No: 9319-M)
• UNI EN ISO 9001:2008 Design, manufacturing of ultrasonic cleaning and thermo-disinfection equipment for medical and industrial sector and environmental analysis (Download Certificate Reg.N: 9319-A)
• UNI CEI EN ISO 13485:2012 Design, manufacturing of ultrasonic cleaning and thermo-disinfection equipment for medical sector.( Download Certificate Reg.No: 9319-M)
• CE 0476 referred only at the product in the Certificate Reg.No: MED 31044 - Equipment for disinfection of medical devices - Brandname: SOLTEC Model: SONICA S.A.M.3 L
• Dichiarazione di conformità classe I, Direttiva 93/42/CEE, 2007/47/CE Vasche ad ultrasuoni e SONICA Sistema Automatico Multifunzione B (2015)
• Dichiarazione di conformità classe IIb, Direttiva 93/42/CEE, 2011/65/UE SONICA Sistema Automatico Multifunzione L (2015)
• Dichiarazione di conformità classe I, Direttiva 93/42/CEE Vasche ad ultrasuoni e SONICA TRENDMATIC 9 and 9 TD (2018)
• Dichiarazione di conformità classe IIb, Direttiva 93/42/CEE SONICA TRENDMATIC 9 TD (2018)