SIMEON Medical masters the world's most demanding audit
SIMEON Medical, one of the world's leading manufacturers of hospital solutions with a focus on operating and examination rooms, is expanding its quality management system with MDSAP certification to meet the highest global requirements for medical device products of class 1. The Tuttlingen-based medical technology company also implemented the ISO 14001 certification to confirm the strict principles that apply within its environmental management system.
With the voluntary certification according to the Medical Device Single Audit Program (MDSAP), SIMEON Medical documents that it meets the highest quality standards in the medical industry worldwide. MDSAP is the initiative of regulators in the US, Canada, Brazil, Australia and Japan and aims to harmonize the regulatory requirements for medical devices. The requirements of MDSAP certification go beyond those of DIN EN ISO 13485.
In addition, in contrast to DIN EN ISO 13485, the MDSAP certification grants the national health authorities (such as the FDA) access to the certification report of the individual companies. This transparency strengthens the high degree of trustworthiness of SIMEON Medical's quality management among customers worldwide.
"Within the competition, SIMEON Medical is leading the way with comprehensive quality management certification. In addition, we are optimally positioned to meet the worldwide requirements for quality management systems in medical technology today and in the future, "says Tobias Lang, Managing Director of SIMEON Medical. Canada, for example, is the first country that no longer accepts DIN EN ISO 13485 as the only certification for quality management in medical technology, but requires certification in accordance with MDSAP. It is predictable that other countries will follow soon.
Commitment to the environment
In SIMEON Medical strict principles apply for quality management as well as the environmental management. The fact that environmentally friendly behavior is anchored in the corporate processes of SIMEON Medical, it has now been officially confirmed by the medical technology specialist with certification to ISO 14001. This includes actions such as the use of recyclable, high-quality materials and regulations for waste and hazardous materials management. Comprehensive emergency management makes it possible to identify dangers in production and thereby prevent possible negative effects on the environment. In addition, SIMEON has a continuous improvement process to achieve its environmental performance goals.