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.
About Endomagnetics
Endomagnetics was founded to solve cancer staging and healthcare challenges through the application of advanced magnetic sensing technology and nanotechnology. Endomagnetics 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.
The company’s first product, the SentiMag®, is an ultrasensitive hand-held probe for tracking injected Sienna+™ nanoscale magnetic materials in the human body. Cambridge, UK-based Endomagnetics is in the process of delivering its technology to global markets. For more information please visit http://www.endomagnetics.com/.
About BSI Group
BSI was the world's first national standards body and has a globally recognized reputation for independence, integrity and innovation in the production of British Standards and standards-related information products that promote and share best practice. Since its foundation in 1901 as the Engineering Standards Committee, BSI Group has grown into a leading global independent business services organization providing standard-based solutions in more than 140 countries. As the UK and Ireland’s premier certification body, BSI’s many thousands of clients range from the largest businesses in the country to government, charities and SMEs. It offers a wide range of assessment products and services covering all the major management system standards as well as many specialised schemes.
Medical Devices are regulated by EU directives. Responsibility to ensure the directives are fully implemented falls to each member state and in the UK this is the Medicines and Healthcare products Regulatory Agency (MHRA). Under the auspices of the MHRA, BSI is an independent review body that conducts conformity assessments to the relevant EU Directives.
http://www.bsigroup.co.uk/