MADRID--(BUSINESS WIRE)-- Andago has been awarded the CE Mark certification1 to market Carefy - its innovative web and mobile patient monitoring application - in all 30 countries across the European Economic Area (EEA). Furthermore, Andago is actively engaged in obtaining the FDA2 approval in order to market Carefy in the USA.
By obtaining the CE Marking, Andago demonstrates that Carefy complies with the Quality and Safety regulations required by the International healthcare market. Andago has successfully completed rigorous audits of its Quality Management System (QMS) and received ISO 13485:20033 and MDD 93/42/EEC4 certificates from SGS, the world’s leading inspection, verification, testing and certification company.
This milestone allows Andago to move forward with its expansion plans in new markets, and boosts trusts for customers and end users, demonstrating that they are using a solution developed with quality and patient safety as top priorities.
Andago commitment has always been to market the best products to improve the ability of physicians and health professionals to perfom daily work with the highest guarantee that they are offering their patients the best care possible.
While there is not official data on how many software-based medical devices and mobile apps similar to Carefy currently have the CE mark and have completed all regulatory requirements for the European Union, the fact is that Andago's development and deployment of compliant apps in the scope of the EU medical devices directives is truly remarkable.
1 EC Certificate Full Quality Assurance System: Certificate ES12/11629 for the product: "Software for Patient monitoring - Medical Software "Carefy" authorised by SGS United Kingdom Ltd, Notified Body 0120 and valid from 30 March 2012 until 30 March 2015.
2 FDA (Food and Drug Administration) is the Consumer Protection Agency of the U.S. Government which monitors medical devices, foods, drugs, biologics, veterinary medicine, and toxicological products.
3 ISO 13485:2003 is an International standard for quality systems supporting the design, development and manufacturing of medical devices.
4 MDD 93/42/EEC is a Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
For further information please visit:
Communications Department Andago
Carolina Pérez, +34 912919978