Patient Rights & Advocacy
1. Reiner Medtech’s Commitment to Patients and Users
At Reiner Medtech S.L.U., we understand that every medical component or device we manufacture contributes to patient safety and quality of life.
We are committed to providing safe, effective, and compliant medical solutions under the EU Medical Device Regulation (MDR 2017/745) and ISO 13485.
Our values are transparency, responsibility, and respect — ensuring our customers and partners can rely on our products with full confidence.
2. Patient and User Rights
a) Right to Product Safety
All Reiner Medtech devices are manufactured under validated processes (IQ/OQ/PQ) and are subject to strict quality control and traceability.
b) Right to Clear and Accessible Information
Patients and healthcare professionals have the right to obtain:
Intended use and product instructions.
Handling and storage conditions.
Warnings, precautions, and contraindications.
CE declarations, IFUs, and technical certificates.
Documentation is available upon request or via our website.
c) Right to Privacy and Data Protection
Reiner Medtech ensures full compliance with EU GDPR 2016/679 and Spanish Law LOPDGDD 3/2018.
All personal and technical data are processed confidentially and never shared without consent or legal obligation.
d) Right to Submit Complaints or Reports
Users may contact Reiner Medtech to report any incident, complaint, or product-related concern.
All communications are handled under our ISO 13485 CAPA process.
Email: consultas@reinermedtech.es
Phone: +34 943 199 363
Mailing address: Reiner Medtech S.L.U., Polígono Industrial Itziar – Parc. 7, 20829 Itziar-Deba (Gipuzkoa) · SPAIN
Office hours: Monday to Friday, 8:00–13:00 and 14:00–17:00 (CET)
e) Right to Response and Follow-up
All inquiries will receive confirmation within 15 business days, along with progress updates and corrective measures if applicable.
3. User Responsibilities
Users must:
Follow all Instructions for Use (IFU).
Avoid any modification or misuse.
Report adverse events promptly.
Store devices under specified conditions.
4. Ethics, Transparency and Compliance
We uphold a culture of integrity and accountability, aligned with the MedTech Europe Code of Ethical Business Practice.
Regular audits verify compliance, and we strive for sustainable and socially responsible operations.
5. Patient Advocate and Quality Department
Reiner Medtech appoints an independent Patient Advocacy Representative to ensure fairness and transparency in all communications.
6. Updates and Validity
This statement was last reviewed on 2025 and may be updated to reflect regulatory or organizational changes.
The current version is always available at www.reinermedtech.es/patient-rights.