Certified OR Integration System by CureVision
1. MDR Class I – Compliance with EU Medical Regulations
📌 What It Means: The Medical Device Regulation (MDR) is the European Union’s framework for ensuring medical device safety and performance.
Why It’s Important:
✔ Ensures compliance with strict EU healthcare standards.
✔ Guarantees safe, effective, and high-quality OR integration technology.
✔ Allows seamless market entry in Europe with CE certification.
2. IEC-60601 EMC – Electromagnetic Compatibility for Safe Operation
📌 What It Means: Prevents medical devices from causing or experiencing electromagnetic interference, ensuring safe use in hospitals and ORs.
Why It’s Important:
✔ Prevents signal interference with life-critical devices.
✔ Enhances operational stability in high-tech environments.
✔ Ensures a secure and interference-free surgical workflow.
3. IEC-60601 LVD – Electrical Safety in Medical Devices
📌 What It Means: The Low Voltage Directive (LVD) regulates electrical safety in healthcare equipment.
Why It’s Important:
✔ Protects patients and healthcare professionals from electrical hazards.
✔ Ensures compliance with global safety standards.
✔ Reduces the risk of power failures or voltage-related malfunctions.
4. OR Hygiene Certification – Infection Control in Surgical Environments
📌 What It Means: Ensures compliance with strict sterilization and hygiene protocols for ORs.
Why It’s Important:
✔ Reduces hospital-acquired infections (HAIs).
✔ Confirms compatibility with sterile medical environments.
✔ Supports compliance with hospital infection control policies.
5. IP65 Protection – Durability Against Environmental Factors
📌 What It Means: IP65-rated medical devices are protected against dust and water, ensuring long-term performance in demanding hospital environments.
Why It’s Important:
✔ Allows easy cleaning and disinfection.
✔ Ensures protection against fluid exposure in ORs.
✔ Enhances device longevity and reliability.
6. DICOM & Color Calibration – Precision in Medical Imaging
📌 What It Means: Ensures compliance with DICOM (Digital Imaging and Communications in Medicine) standards for medical image accuracy.
Why It’s Important:
✔ Delivers high-precision color calibration for diagnostic imaging.
✔ Supports radiology, surgical planning, and real-time visualization.
✔ Enhances diagnostic accuracy for improved patient outcomes.
The Dangers of Using Non-Certified Medical Devices
Hospitals and healthcare providers that use uncertified medical equipment expose themselves to significant risks:
🚨 Patient Safety Hazards – Inaccurate readings, malfunctioning equipment, and sterilization failures can compromise patient care.
🚨 Regulatory Violations – Non-certified devices may fail inspections, leading to legal penalties and fines.
🚨 Operational Downtime – Poorly manufactured equipment increases failure rates, causing delays in surgeries and treatments.
🚨 Data Security Risks – Lack of compliance with international standards may expose hospitals to cybersecurity vulnerabilities.
💡 Solution: By choosing CureVision-certified medical devices, hospitals eliminate these risks and ensure full compliance, safety, and efficiency.
Why Choose CureVision?
At CureVision, we don’t just comply with medical standards—we set the benchmark for safety, reliability, and innovation in Operating Room Integration Systems.
- Uncompromising Patient Safety – Every CureVision system undergoes rigorous testing to meet and exceed global medical regulations.
- Seamless Integration & Compliance – MDR, IEC-60601, OR Hygiene, and DICOM-certified for flawless compatibility with hospital infrastructure.
- Future-proof Technology – Designed to adapt to evolving healthcare needs, ensuring long-term investment protection.
- Engineered for Performance – High durability, IP65 protection, and cutting-edge features guarantee reliable operation in critical environments.
- Global Trust & Recognition – Approved for Europe, Turkey, and international healthcare markets, making CureVision the preferred choice for leading hospitals.
Don’t compromise on quality. Choose CureVision for a safer, smarter, and more efficient OR.
Contact us to discover how CureVision can transform your surgical workflow.