Improving quality with ISO 13485 certification
The basis of devices and related services used in healthcare is that safety is not compromised. Patient’s well-being is the priority number one and the device/service must work in accordance with its purpose. For this reason, within the industry there are quality standards and systems that can be used to ensure compliance with safety regulations.
Medanets quality management system has been developed in 2008, and already back then we set a goal that the system will be part of our daily operations. In November 2010, VTT audited our quality management system in accordance with ISO 13485 standard. After this, our quality management system has been maintained and audited annually by VTT, and as of 2012 by LRQA (Lloyd Register Quality Assurance).
ISO 13485 is the most widely used quality management system which defines quality standards for medical devices and related services. Initially, ISO 13485 standard has been written for manufacturers of medical devices and applying the requirements for software development has required finetuning. Medanets staff has been involved in the writing and developing process of the quality manual, which has contributed to apply the standard for software product development as well.
The quality management system brings quality to our daily operations, improves patient safety, minimize product-related risks and helps to increase efficiency.
An audited quality management system is a guarantee that we fulfill the requirements for Class I Medical Device. An essential part of the quality management system is also responding to customer feedback, which we take into consideration by linking the feedback directly to our product development – our solutions are part of caregiving so customer-oriented operation is the basis of everything.