Quality commitment
Bio-Sensing Solutions S.L (DyCare) was born with the ambition to provide the most innovative Digital-Health solutions in the field of rehabilitation, always maintaining the commitment to provide high-quality products and offer all the guarantees of safety and performance to all its users.
Certified organization
DyCare’s quality management system ensures and promotes the excellence of our digital solutions throughout their life cycle, from design to implementation. That is why DyCare has received certification according to ISO 13485:2016, evaluated by the accredited entity Kiwa Cermet SpA, as evidence of compliance with the highest quality standards and applicable regulatory requirements for medical devices..
In addition, as a Spanish manufacturer of medical devices, DyCare has the prior license for the operation of medical facilities granted by the Spanish Agency for Medicines and Health Products (AEMPS), as the organization is complying with local regulatory requirements.
Product guarantee
The digital solutions developed and marketed by DyCare have the CE marking as medical devices, as a guarantee that they meet all regulatory requirements related to the safety and aptitude of use of the product established by the European regulatory framework. In addition to this, the products meet the requirements of other jurisdictions, such as the case of the United Kingdom (UK).
In addition to the regulations applicable to medical devices (“Medical Devices”), DyCare and its digital solutions comply with the European Regulation for the Protection of Natural Persons with regard to the treatment and free movement of personal data EU2016/679(GDPR), as well as The requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPPA) applicable to the treatment of “Protected Health Information” in the context of “Business Associated”.
Finally, the Rehub® digital solution has the recognition of good practices of cloud software based architecture granted by Amazon Web Services (AWS), after a satisfactory technical evaluation.
- A paper printed version of the Rehub® Instructions for Use, and/or
- A previous version of the current Rehub® instructions for use, both in electronic and paper format.
These documents will be provided at no additional cost and in the official language of the Union of the country to which the account corresponds, within a maximum period of six calendar days from receipt of the request. If you need any of this information, please request it from our support team at support.rehub@dycare.com.