Frankfurt, July 31, 2013 – CSA Group, a leading global testing and certification organization, and BSI, the business standards company, have formed a strategic alliance for the provision of global market access solutions to clients in the electronic medical device sector (electro-medical). Through the alliance, CSA Group will certify and test electro-medical products to the applicable electrical standards for safety and performance. BSI will provide conformity assessments to regulatory requirements in different regions worldwide (e.g. the European CE Mark) as well as certification to the international standard ISO 13485 (quality management system for medical devices).
"By entering into this strategic alliance, CSA Group and BSI will be able to provide clients with a single point of contact for multiple certifications of their electro-medical devices," said Magali Depras, Vice President, Europe, CSA Group. "Together we will provide streamlined and economical business solutions to global manufacturers that require multiple certifications for different electro-medical markets."
Electro-medical products include patient monitoring equipment, anesthetic and respiratory equipment, equipment used in surgical interventions as well as large-scale devices for medical imaging. The German domestic market alone for electro-medical products totaled €1.15 billion in 2010 according to German trade association ZVEI.1
Gary Slack, Director of MedTech at BSI comments "Bringing an electro-medical device to market is a complex process and our complementary strengths will help make this process more efficient for manufacturers. BSI and CSA Group's global reach and breadth of technical expertise will provide market access to Europe, Asia and North America for existing and future clients."
The alliance will help provide electro-medical equipment manufacturers with a faster and more predictable route to achieving CE marking. CSA Group and BSI clients will benefit from improved global market access via increased ability to meet local and regional requirements with BSI and CSA Group providing specialist knowledge of EU and North American markets.
In addition to the strategic alliance between the organizations, CSA Group is purchasing BSI Deutschland's testing business – previously a part of BSI/EUROCAT – for testing of electronic medical devices to International Electro technical Commission (IEC) and IEC-Based Standards.
"The growth of our Frankfurt testing and certification capabilities for electro-medical devices through the acquisition of these assets is at the core of our commitment to provide localized testing and certification services to our German and European customers with global electro-medical businesses," said Ms. Depras.
CSA Group will immediately take ownership of BSI's testing business for electronic medical devices. To ensure no disruption to customer service and current contracts, CSA Group will operate under lease from the BSI facilities in Frankfurt until construction of its own new Frankfurt laboratory facility is completed in early 2014. CSA Group is committed to retaining the talent, expertise and knowledge of current BSI employees.
About CSA Group
CSA Group is an independent, not-for-profit membership association dedicated to safety, social good and sustainability. Its knowledge and expertise encompass standards development; training and advisory solutions; global testing and certification services across key business areas including hazardous locations and industrial, plumbing and construction, medical, safety and technology, appliances and gas, alternative energy, lighting and sustainability; as well as consumer product evaluation services. The CSA certification mark appears on billions of products worldwide. For more information about CSA Group visit www.csagroup.org