TORYTRANS S.L in its continuous intent for technological innovation of its designs and products, has obtained the positive resolution of the project presented within the Innova program – in front of the committee of Castilla - La Mancha with the project "CE Marking, implementation of regulations and certification for the manufacturing and commercialization of ICT systems applied to the treatment of the APNEA/HIPOPNEA syndrome of sleep (OSA) ".
The action to be executed is focused on the development of an innovative range of products for the diagnosis and treatment of sleep apnea, with the general objective of carrying out a parallel project, versed in the adaptation of the productive, organizational, quality control and scientific-technical capacity of the entity, with regards to the current medical regulations and to the fulfillment of the requirements for obtaining the CE mark for the range of newly developed products, with their corresponding certifications.
As a result, this innovation project, is looking for the following specific technical objectives:
1. CE marking of the family of products for the diagnosis and treatment of sleep apnea (OSA).
- Technical documentation (Technical File)
- Trials
- Certification of CE marking
2. Implementation of medical regulations ISO-13485
- Documentation procedures and processes
- Implementation
- Certification regulation ISO - 13485
3. Obtaining of a manufacturer's license.
This subsidy is subject to the regulation (EU) No. 651/2014 of the Commission from June 17, 2014, declaring certain categories of aid compatible with the internal market in application of Articles 107 and 108 of the Treaty. And will be financed by the Autonomous Community of Castilla-La Mancha and, where appropriate, by the European Fund for Regional Development (ERDF) with an intensity of 80%, through the Operational Program ERDF 2014-2020 of Castilla-La Mancha.