EUROLAB Leads the Way in EMC Testing and Certification for Electronic Medical Devices Worldwide
EUROLAB is leading the way in EMC testing, certification, and global approvals for Class I, II, and III electronic medical devices. Collaborating closely with manufacturers of electrical medical devices, EUROLAB specializes in identifying the necessary tests, certifications, and evaluations required to ensure compliance with electromagnetic safety standards and international regulations. Their suite of medical device EMC services includes rigorous testing in line with the international IEC 60601-1-2 standard, guaranteeing the electromagnetic safety, performance, and effectiveness of medical devices and equipment for swift global market access.
EUROLAB's EMC laboratories' accreditations and approvals include ISO/IEC 17025, ISO 9001 certification, National Certification Agency (NCB) recognition, and Certification Agency Test Laboratory (CBTL) certification issued by NVLAP (National Voluntary Laboratory Accreditation Program), A2LA (American Association for Laboratory Accreditation), or UKAS (United Kingdom Accreditation Service).
EUROLAB offers a comprehensive array of medical device testing and certification services:
- Medical Device Battery Test: Ensuring the reliability and performance of medical device batteries.
- Microbiological Analysis: Evaluating the microbiological safety of medical devices.
- EMC Test: Rigorous electromagnetic compatibility testing to meet international standards.
- Product Safety Test: Ensuring the safety and effectiveness of medical devices.
- Radio and Wireless Tests: Evaluating wireless components and connectivity.
- Environmental Tests: Assessing a device's performance in different environmental conditions.
- International IECEE CB Certification: Facilitating international market access through CB certification.
- CE Marking of Class I, IIa, IIb, and III Devices: Ensuring compliance with EU directives.
For medical device manufacturers seeking to integrate wireless features into their products, EUROLAB provides invaluable support in obtaining the necessary approvals for wireless medical devices. They work with a variety of technologies, including MedRadio, Wireless Medical Telemetry, RFID, Wi-Fi®, Bluetooth®, and GSMTM radio applications.
As wireless functionality becomes increasingly prevalent, wireless cohabitation assessments have become essential. EUROLAB has developed a range of test packages to address these critical performance and security concerns.
EUROLAB's expertise spans a wide range of harmonized standards for medical devices, including the EN/IEC 60601 series, ANSI C63.27 for wireless coexistence, AIM 7351731 for RFID evaluation, US FDA 510(k) clearance, the Medical Device Directive (MDD), and ISO 14971 risk management. Their seasoned regulatory team provides invaluable support and guidance.
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