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.
Dr Andrew Shawcross, who led the establishment of Endomagnetics’ quality system, said: “We are delighted to have received these certifications. They reflect a substantial effort by our team and reinforce our commitment to quality.”
Concurrent with the quality certification, Dr Shawcross has been promoted to Chief Operating Officer. Eric Mayes, CEO commented: “This [certification] is an important milestone for Endomagnetics, and a strong sign of our quality commitment to partners and customers. Andy’s promotion to COO reflects his significant efforts and achievements since joining in 2011.”
The quality certification comes following a comprehensive site audit, and Endomagnetics’ customers can be confident that the company has in place best practice systems to ensure the consistency and high quality of its medical devices. The SentiMag® probe is used to detect the presence of Sienna+® as part of the sentinel lymph node biopsy procedure regarded as the current standard of care. Endomagnetics’ technology replaces the need for radioactive tracer materials and so opens up the availability of this important technique to many more patients and clinicians worldwide.