New Class I Medical Devices Set the Trend For Higher Safety And Quality Standards For Medical Software Solutions
GE Healthcare, the US$17 billion healthcare business of global technology, media and financial services company, General Electric company (GE), today announced that its Centricity Clinical Information Systems (CIS), Centricity Anesthesia and Centricity Critical Care received the CE-Mark as a medical device according to the European Union Medical Device Directive (MDD) 93/42/EEC.
High quality medical care and efficient information management is key in anesthesia and intensive care. Live critical data must be available any time at the point of need. Since 2003, GE Healthcare demonstrates its vision to deliver clinically deep applications with an ISO13485 certified process for developing medical devices. With a part of its Centricity clinical product line being CE marked, GE is driving this vision to the next level.
The newly CE marked IT solutions will help to reduce human errors in documentation and thus ensure a higher quality in patient care. Customers can now rely on software that is certified and compliant to regulatory requirements and beyond that offers an audited development process for handling qualified processes in accordance with the relevant standards under the Medical Device Directive.
“We are well known as being trendsetters in healthcare,” said Nicolai Mokros, General Manager at GE Healthcare Integrated IT Solutions for CIS in Europe, Middle East and Africa (EMEA). “With this initiative we stay abreast of the changing markets in EMEA, which more than ever before demand higher safety standards and proven compliance in healthcare information technology. As these changes become more evident, European regulatory authorities will put higher focus on precise requirements for hospital and clinical information systems. We are proud to be the engine driving this trend and taking an important step for our broad customer installed base in EMEA by CE marking our solutions,” emphasized Mokros.
To CE-Mark clinical IT solutions as medical devices is a logical sequence in the eHealth revolution. In the future, the frontiers between hospital IT and medical equipment will disappear. GE Healthcare is among the forerunners to develop clinically deep IT solutions for planning, documenting and managing vital medical data, and in parallel, bring to market medical software that fulfils the safety and quality requirements of a medical device.