Endomagnetics, the company developing a portfolio of products to improve the standard of breast cancer management, has achieved certification to an international quality standard.
Endomagnetics’ Quality Management System has been evaluated and certified by BSI as meeting the standards of ISO 13485:2003. This international quality standard specifies the requirements for a comprehensive management system for the design and manufacture of medical devices. In addition, Endomagnetics has met the scope necessary for an upgrade to Annex II of the Medical Device Directive 93/42/EEC, applicable to both its SentiMag®instrument and Sienna+® tracer material. The company’s current product line is ‘CE’ certified.
Endomagnetics was founded to solve cancer staging and healthcare challenges through the application of advanced magnetic sensing technology and nanotechnology. The business is developing a portfolio of medical device products based on a patented ability to detect magnetic materials in the human body with exceptional sensitivity. The technology was originally developed at University College London and the University of Houston. For more information please click here.
Source: Business Weekly & Endomagnetics