The British Standards Institute (BSI) has awarded ISO 13485:2003 quality certification to Endomagnetics' quality management system.
In addition, the company has met the scope necessary for an upgrade to Annex II of the Medical Device Directive 93/42/EEC, which is applicable to both its SentiMag instrument and Sienna+ tracer material.
As part of the sentinel lymph node biopsy procedure, which is regarded as the current standard of care, the SentiMag probe is used for detecting the presence of Sienna+.
Andrew Shawcross, who led the establishment of quality system, has been promoted to chief operating officer.
Endomagnetic CEO Eric Mayes said the certification is an important milestone for the company and is based on the quality commitment of its partners and customers.
"Andy’s promotion to COO reflects his significant efforts and achievements since joining in 2011," Mayes added.