Eaulier Medical Certifications

The IECEE CB (Certification Body) Scheme is an international system for the mutual recognition of test results and certificates for electrical and electronic equipment. Operated by the International Electrotechnical Commission (IEC), it is essentially a global “passport” for electronic products. The system operates on a core philosophy: “one product, one test, one certificate.” If you manufacture an electronic product, you can have it tested by a recognized Certification Body Testing Laboratory (CBTL). Once it passes, a National Certification Body (NCB) issues a CB Test Certificate, recognised over 50 countries.

It's tested for: Electrical Safety, Thermal Safety & Fire Resistance, Mechanical Safety, Electromagnetic Compatibility (EMC), Energy Efficiency & Performance, Hazardous Substances Used.

Categories: Medical electrical devices, Measurement, control, and laboratory equipment, Information Technology (IT) and office equipment and other electrical devices.

SGS stands for Société Générale de Surveillance (French for General Society of Surveillance). Headquartered in Geneva, Switzerland, it is the world's leading inspection, verification, testing, and certification company. If the IEC (from the CB Scheme) writes the rules and standards, SGS is one of the primary commercial laboratories hired to prove a product actually meets those standards. They act as an independent, third-party auditor to verify that products, systems, and supply chains meet international, national, or customer-specific regulations.

It's tested for: Regulatory Compliance, Safety and Performance, Material and Chemical Analysis, Quality Control (Inspection), Systems Certification–ISO 9001 (Quality Management).

Categories: Medical therapeutic devices – IEC 60601-1 Series: the foundational international standard for the electrical safety and essential performance of medical electrical equipment. ISO 13485: certification of the manufacturer's Quality Management System (QMS). Biocompatibility (ISO 10993): if the therapeutic device makes physical contact with the patient's body, SGS tests the materials to ensure they do not cause allergic reactions, toxicity, or cellular damage.

Global Market Access: SGS conducts the necessary audits and clinical data reviews to help manufacturers secure the European CE Mark under the Medical Device Regulation (MDR) or clear FDA 510(k) requirements in the United States.

Letter of Confirmation on Eaulier Medical devices by SGS Japan on behalf of SGS Belgium.

Human Clinical Studies on Parkinson Disease by Dalian Eaulier Hospital.
Clinical subjects: 77 Parkinson’s cases.

Human Clinical Studies on Cognitive Neuroscience by Dalian Eaulier Hospital.
Clinical subjects: 44 Parkinson’s cases.