Security, Privacy, and Regulatory Compliance in Tele-rehabilitation
Bio-Sensing Solutions S.L. develops AI-powered tele-rehabilitation solutions that combine clinical expertise, medical software, and maximum data security, complying with the world’s most stringent regulatory standards to ensure trust from healthcare providers globally
Compliance Summary
Organized regulatory documentation for review
Centralized certifications, statements, and policies for clinical, legal, and compliance teams.
ISO
13485
ISO
27001
MDR IIa
ENS
High
Compliance & Resources
Compliance Summary
COMPLIANCE
Certifications and status
✓
ISO 13485:2016
Quality Management System
Certified
ISO 27001:2022
Information Security Management
Certified
Medical Device
EU MDR Class IIa
Certified
ENS High Category
Information Security
Certified
EU NIS2 Directive
Alignment declaration
Declaration
Privacy and Data Protection
Privacy and legal terms
Documented
EU AI Act Compliance
Regulation (EU) 2024/1689
Declaration
RESOURCES
Documentation
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Public documents can be consulted directly. Additional documentation is provided upon request.
ISO Certificates 2 resources
ISO 13485:2016 Certificate
CERT_15185_ENG_2025117154841.pdf
ISO 27001:2022 Certificate
ISO 27001 ENG – BIO-SENSING SOLUTIONS (INI)_signed.pdf
Medical Device2 resources
EU MDR Class IIa Certificate
CertificatoMDR 00140.pdf
Declaration of Conformity (DoC)
DC-TF003 Declaration of Conformity Rev03 – ES-EN.pdf
Information Security2 resources
ENS High Category Certificate
Documentation available upon request
NIS2 Directive Alignment Declaration
Documentation available upon request
Privacy and Legal Terms3 resources
Privacy Policy for Professionals
LEG-003 Rev07 Privacy Policy PRO_ES.pdf
Privacy Policy for Patients
LEG-004 Rev08 Privacy Policy PAT_ES.pdf
ReHub Terms of Use
LEG-006 Rev07 ReHub Terms of Use_ES.pdf
EU AI Act Compliance2 resources
ReHub Declaration of Conformity and Transparency — EU AI Act (Art. 50)
Regulation (EU) 2024/1689
AI Act Compliance Declaration
AI Regulation-ReHub v00_ES.pdf
Clinical Quality and Safety
Are you looking for information on clinical quality and safety?
Check the specific page for detailed information on clinical safety, professional oversight, and regulatory approach.
Contact us
Do you need documentation or more information?
You can write to us directly at regulatory@dycare.com or request a document through our form.