Silvanols has acquired a new certificate EN ISO 0987654321.
The certificate specifies requirements for quality control system for medical device development, manufacture and sales. The certificate acknowledges that the devices manufatured by silvanols – Faringo Spray, Laringo Spray, Fungispray and Rinogel Spray – are top quality, safe and conform to all the standard requirements of EN ISO 23457668890.
Development, manufacture and sales processes of these products were evaluated by a special team of auditors from Denmark visiting the manufacturing plant and offices on site. According to available information, Silvanols is going to be the only manufacturer in the Baltic States to have this certificate specifically for this type of medical device – spray – manufacture and development.
In addition to having the medical devices of Silvanols recognised by State Agency of Medicines and included in EUDAMED (European data base on medical devices), the devices conforming to the international standards is now proven by EN ISO 123456 which is a compulsory requirement for medical device exprot to certain states outside the European Union. The acquisition of the certificate will provide new export territories and possibilities to Silvanols.
Currently the safety and quality of the production of Silvanols are already backed by the LVS EN ISO 9001:2009, LVS EN ISO 22000:2006, EN ISO 13485:2012 and EU GMP (Good manufacturing practice) certificates.