All SBM Sistemi medical products are marked EC under the Medical Device 93/42 / EEC Directive and also conform to a set of international standards as applicable.
However, the interior of the medical commitment SBM Sistemi for product quality goes beyond the adherence of internationally recognized standards and extends in the attitude of our highly skilled production staff and the quality dedicated team, who are always aware the fact that the products they manufacture are used to save lives in critical care applications both locally and worldwide.
ID registration BD/RDN
I.C.P. OSA registration number at the Ministry: 1556084/R
I.C.P. IOL registration number at the Ministry: 1340867/R
I.C.P. SLIT LAMP registration number at the Ministry: 1340861/R
I.C.P. SLIT LAMP PLUS registration number at the Ministry: 1340862/R
I.C.P. TEARSCOPE registration number at the Ministry: 1340864/R
I.C.P. MEASUREMENT registration number at the Ministry: 1340865/R
Furthermore all devices are certified CE and are accordant to the European regulations in force.
Electro medical test – photobiological test – etc
ISO 13485 Quality Management System for Medical Devices
ISO 13485ISO 13485 is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.
ISO 13485: 2003 has been harmonized against the three EU Medical Devices Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices), so certification to this standard by an accredited certification body such as ECM automatically demonstrates compliance with specific clauses in these directives.
The certification of a quality management system, specifically for medical devices, to ISO 13485 is essential, for medical companies which export their products to the global market. In the European Union, the fulfilment of EU Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.