COMTRADE CERTIFIED AS A MEDICAL SOFTWARE SOLUTION DEVELOPER
POSTED ON 12.04.2016
Comtrade announced it successfully passed ISO certification as a developer of medical software solutions. This certification confirms that Comtrade’s software solutions for medical devices meet the quality requirements and comply with international standards. Comtrade’s engineering solutions comply with the ISO 13485:2003 standard, while this certificate also confirms compliance with the risk management processes for medical devices (ISO 14971:2007) and the medical device software lifecycle (IEC 62304:2006) standards.
The certification highlights the years of experience Comtrade has with the development of software solutions for medical devices and confirms that they meet the highest industry standards. At the same time, it facilitates customers’ digital transformation and reduces their time-to-market for innovative products.
In addition to the normally high level of services delivered, the ISO 13485 certificate provides Comtrade’s customers with the confidence that its software solutions can be quickly and easily integrated with existing systems and projects to eliminate additional regulatory burdens.