INFOMED pioneer in obtaining health software and ISO 9001 ISO 13485 standards in business management

Barcelona, October 2012.- Infomed (Group Henry Schein) the Spanish company leader in healthcare software, has been one of the first companies in obtaining the certification of medical devices ISO 13485: 2003 for medical and dental software Spain.

This quality Norma de Gestión is specific to organizations providing medical devices, with the aim of facilitating the harmonised regulatory requirements of sanitary products for quality management systems.

INFOMED as manufacturer and supplier of dental and medical software, complying with its commitment to innovation, quality and service, has audited and certified the design and manufacture of products of software (Ortomed and Gesimag) intended to perform medical imaging, record them and process measurement.

This certification involves the marketing of their products in software of management of “Gesimag” images and analysis cephalometric “Ortomed” with the CE marking required by Europe for the commercialization and subsequent use of products.

On the other hand the standard ISO 13485 includes some particular requirements for medical products and excludes any of the requirements of the ISO 9001 standard that are not suitable as regulatory requirements. Therefore, in parallel, the company with the objective of certifying not only their medical devices but also the management of internal quality of the company as well as the services provided to its customers, has made complement the audit process for the obtention of the ISO 9001 standard, achieving both certifications in September 2012.

The implementation of this standard of international character, ISO 9001, allows you to manage these services with the same criteria of efficiency using leading business organizations and gives guarantees of quality of work processes that are carried out.

Both audits and certifications have been conducted by BSI Group, one of the most important certifying management systems in the world, with more than 60,000 registered customers worldwide and more than 100 years of experience in 150 countries.

“The main benefit of this initiative are Infomed customers domestic and international, that will have the security of working with a reputable company and products that meet the maximum guarantees of information, safety, effectiveness and quality at all times” says Santiago SoláGeneral director of Infomed.