Nanotechnology Now

Our NanoNews Digest Sponsors
Heifer International



Home > Press > Endomagnetics Announces Quality Certification and COO Appointment

Abstract:
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 Announces Quality Certification and COO Appointment

Cambridge, UK | Posted on October 1st, 2012

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 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.

www.bsigroup.co.uk

For more information, please click here

Contacts:
Editorial contact:
Terry Nicklin
KeynotePR Ltd
Tel: +44 (0)7923 540695


Company contact:
Dr Eric Mayes
CEO
Endomagnetics Ltd
Tel: +44 (0)1223 437131

Copyright © Endomagnetics

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Researchers develop artificial building blocks of life March 8th, 2024

How surface roughness influences the adhesion of soft materials: Research team discovers universal mechanism that leads to adhesion hysteresis in soft materials March 8th, 2024

Two-dimensional bimetallic selenium-containing metal-organic frameworks and their calcinated derivatives as electrocatalysts for overall water splitting March 8th, 2024

Curcumin nanoemulsion is tested for treatment of intestinal inflammation: A formulation developed by Brazilian researchers proved effective in tests involving mice March 8th, 2024

Nanomedicine

High-tech 'paint' could spare patients repeated surgeries March 8th, 2024

Researchers develop artificial building blocks of life March 8th, 2024

Curcumin nanoemulsion is tested for treatment of intestinal inflammation: A formulation developed by Brazilian researchers proved effective in tests involving mice March 8th, 2024

The Access to Advanced Health Institute receives up to $12.7 million to develop novel nanoalum adjuvant formulation for better protection against tuberculosis and pandemic influenza March 8th, 2024

Announcements

What heat can tell us about battery chemistry: using the Peltier effect to study lithium-ion cells March 8th, 2024

Curcumin nanoemulsion is tested for treatment of intestinal inflammation: A formulation developed by Brazilian researchers proved effective in tests involving mice March 8th, 2024

The Access to Advanced Health Institute receives up to $12.7 million to develop novel nanoalum adjuvant formulation for better protection against tuberculosis and pandemic influenza March 8th, 2024

Nanoscale CL thermometry with lanthanide-doped heavy-metal oxide in TEM March 8th, 2024

Appointments/Promotions/New hires/Resignations/Deaths

The National Space Society Mourns the Passing of Robert Krone, Founder of the Kepler Space Institute: Krone's Visionary and Humanistic Approach to the Study of Space Communities and Settlement Was Unique September 22nd, 2021

Leibniz Prize winner Professor Dr. Oliver G. Schmidt moves to Chemnitz University of Technology: President Professor Dr. Gerd Strohmeier refers to an 'absolute top transfer' September 10th, 2021

JEOL USA Welcomes New Managing Director, Hidetaka Sawada April 19th, 2021

The National Space Society Remembers Ben Bova : NSS Mourns the Loss of a Visionary NSS Leader December 2nd, 2020

NanoNews-Digest
The latest news from around the world, FREE




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project