We are providing Iso 13485:2003. Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 9342EEC, 90385EEC and 9879EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 andor ISO 13485 and ISO 14971 by a Notified Body. The result of a positive assessment is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union.

We are providing ISO 31000:2009. ISO 31000 seeks to provide a universally recognized paradigm for practitioners and companies employing risk management processes to replace the myriad of existing standards, methodologies and paradigms that differed between industries, subject matters and regions.

We are providing Iso 50001:2011. ISO 50001:2011 specifies requirements applicable to energy use and consumption, including measurement, documentation and reporting, design and procurement practices for equipment, systems, processes and personnel that contribute to energy performance. ISO 50001:2011 applies to all variables affecting energy performance that can be monitored and influenced by the organization. ISO 50001:2011 does not prescribe specific performance criteria with respect to energy. ISO 50001:2011 has been designed to be used independently, but it can be aligned or integrated with other management