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Quality & Regulatory

Commitment to quality

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 keeping 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 guarantees 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, assessed 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 holds the previous license to operate medical device facilities granted by the Spanish Agency of Medicines and Medical Devices (AEMPS), as the organization is in compliance with local regulatory requirements.

Product Guarantee

The digital solutions developed and marketed by DyCare bear the CE marking as medical devices, as a guarantee that they comply with all regulatory requirements related to the safety and suitability for use of the product established by the European regulatory framework. In addition to this, the products comply with the requirements of other jurisdictions such as the United Kingdom (UK)

In addition to the regulations applicable to medical devices, DyCare and its products comply with the General Data Protection Regulation (GDPR), defined in the privacy policies of each of our solutions.

Finally, the ReHub® digital solution is recognized by Amazon Web Services (AWS) for best practices in cloud-based software architecture, following a satisfactory technical evaluation.

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