Certifications
HOME – CERTIFICATIONS
- Certified to International Standards
Certified compliance with the highest international standards of quality and safety
Our systems are certified to the strictest healthcare standards, guaranteeing uncompromising quality, safety, and reliability.
General Certifications
Quality Management
- ISO 9001:2015
Information Security
- ISO 27001
Medical Devices
- ISO 13485
Artificial Intelligence Management
- ISO 42001
Area-Specific Compliance
Laboratory
- CE IVD
- FDA Clearance
Blood Bank
- MDR Class IIb
- FDA Cleared
- Transfusion FDA Pending
Area-Specific Compliance
Pathology
- CE IVD
Radiology Imaging
- MDR Class IIa
Clinical Imaging
- MDR Class I
- CE Class IIa
Area-Specific Compliance
Critical Care
- MDR Class IIa / IIb
Telemedicine
- MDR Class IIa
- Our Backing
Strategic Partnership Backed
by a Global HealthTech Leader
By partnering with TESI Group, we bring proven medical technology to dozens of countries,
with systems running in internationally recognized hospitals.
Do you need regulatory compliance documentation?
We provide all the technical documentation
you need — certifications, audit reports, and declarations
of conformity — for accreditation processes or supplier evaluations.
- FAQs
Common Questions about Certifications
We answer the most frequent questions about our certifications, compliance standards, and validation procedures.
ISO 13485 is a standard specific to medical device manufacturers, including software. It means our development, testing, documentation, and quality management processes meet the highest international standards to ensure safety and effectiveness in clinical environments.
Yes. Our systems are designed to meet HIPAA (Health Insurance Portability and Accountability Act) requirements, including data encryption at rest and in transit, granular access controls, automated audit logs, and built-in privacy policies to protect sensitive health information.
The CE Mark is the European conformity marking that allows marketing medical devices in the EU under the MDR regulation. The FDA (Food and Drug Administration) is the U.S. regulatory authority. Both require extensive technical documentation, but their processes and specific requirements differ by region.
ISO certifications require annual surveillance audits and full renewal every three years. Regulatory compliance (FDA, CE) is maintained through ongoing post-market surveillance and updates to the technical documentation when there are significant software changes.
Yes. We provide all required documentation, including original ISO certificates, CE Declarations of Conformity, FDA 510(k) clearance letters (where applicable), audit reports, and MDR technical documentation. Contact us at luisuribe@urdr.net to request the complete package.
We maintain continuous regulatory monitoring and update our software to comply with new requirements at no additional cost as part of our maintenance program. We proactively notify clients of relevant regulatory changes and coordinate any required updates.