After a long process, ThermoHuman has obtained the CE certificate in accordance with the European Medical Device Directive MDD 93/42/CEE Class I. Likewise, the company has voluntarily implemented a quality system compliant with the requirements of the EN-ISO 13485:2016 standard. This milestone is reflected in this officially published declaration of conformity and places ThermoHuman software as the first thermography software applied to health and sports to obtain such a certificate.
ThermoHuman has gone through a process in which it has implemented a quality system subject to ISO 13485:2016, ISO 14971:2020, ISO 15223-1:2017, ISO 62304:2007 and ISO 62366-1:2015 standards. This system ensures that all necessary measures have been taken to ensure product safety and that our production capacity is adequate to manufacture compliant products, based on a clinical evaluation to demonstrate performance and the absence of unacceptable risks, following the provisions of Annex VII of Directive 93/42/EEC.
Additionally, it has been possible to obtain the Prior Operating License for the Installation of Healthcare Products issued by the Spanish Agency for Medicines and Health Products (AEMPS). The AEMPS is the state agency attached to the Spanish Ministry of Health, responsible for guaranteeing the quality, safety, efficacy and correct information of medicines and health products to the society.
Although the license has been valid since March 2021, it was made official by the AEMPS in October of this year. This certification is a fundamental requirement for ThermoHuman, since it accredits us as manufacturers of software for "the management and display of thermographic information for healthcare professionals and researchers in sports sciences". For this, we have had the external and independent help of PS Consulting professionals, who have advised and guided us to achieve all the demanded requirements and the implementation of the quality system.
From this moment on, ThermoHuman® is no longer just a scientifically, but also clinically validated software. This validation is the maximum evidence of compliance with the requirements that apply to it, as a result of health and quality accreditation at both national and European level, which recognizes ThermoHuman® as the first and only thermography software applied to health and sports that is compliant with all the requirements to obtain the CE Certificate as a Medical Device.
ThermoHuman has had the support of the Funds of the European Union and the Community of Madrid through the Operational Programme on Youth Employment. Likewise, ThermoHuman within the framework of the Export Initiation Program of ICEX NEXT, had the support of ICEX and the co-financing of the European Regional Development Fund (ERDF).
Thermohuman has received funding from the Centre for the Development of Industrial Technology (CDTI), in participation with the European Regional Development Fund (ERDF), for the R+D activities involved in creating a new tool, based on thermography, for the prediction and prevention of rheumatoid arthritis. See project detail.
