Leading Nordic software for medical multimedia gets CE Certification
Mawell has implemented a complete Quality Management System for its software solutions and received CE certification for Mawell M7 MediMaker software. The Quality System and CE mark are great examples of the long-term commitment of Mawell to continuously improve quality and operations. These achievements also highlight Mawell’s agility and capability to react quickly on changing regulations in the healthcare sector.
European Union Medical Directive chanced on March 21st 2010 and is now more clearly applied also to software used by healthcare professionals. This means that software can be interpreted as a Medical Device which needs a CE marking before it can be brought to the market.
M7 MediMaker is the leading Nordic software for producing, storing, reporting and exchanging medical multimedia content. M7 MediMaker is widely used within numerous medical specialties for examination and reporting purposes. Thousands of healthcare professionals are using the software daily in more than 100 healthcare service provider organizations. CE mark ensures that M7 MediMaker is compliant with directive MDD 93/42/EEC and Mawell Quality Management System meets the provisions of Directive’s Annex II.
”According to the change in the Directive healthcare organizations in the EU member countries are going to demand the CE certification for the software to be used and purchased for the professional healthcare. We believe that Mawell’s quick reaction to this change will give us a competitive advantage in public procurements and also gives assurance to our existing customers that our software meets the regulatory, safety and quality requirements also in the future.” points out Timo Koistinen, EVP in charge of Mawell Software Solutions.
Mawell’s Quality Management System is implemented based on the ISO 13485 which is Quality Standard for Medical Device Manufacturers. Comprehensive Quality System that takes in consideration the mandatory requirements from the authorities will bring added value to customers by enabling higher quality software deliveries and improved customer support and ensuring patient safety.
”Implementing the quality system has brought coherence to our operational processes and increased personnel’s awareness and knowledge on quality, quality systems and improvement. Our Quality System and processes are part of everyday work and are improved continuously in a controlled way.” says Taina Kolehmainen, Quality Manager for Mawell Software Solutions and Project Manager of quality system implementation project.
Mawell is an innovative and fast growing Nordic healthcare company. We provide our solutions internationally to private and public healthcare organizations and pharmaceutical companies. We rely on extensive industry knowledge, interoperability, open standards and patient centric technology. To our customers our solutions provide higher efficiency – more time to care. Our company is the market leader in Virtualized Patient Informatics (VPI) in Northern Europe. www.mawell.com.