Medical Device EMC Test

EUROLAB is the perfect partner for EMC testing, certification and global approvals of your Class I, II and III electronic medical devices.

EUROLAB works with manufacturers of electrical medical devices to identify the tests, certification and evaluation required to comply with electromagnetic safety standards and international regulations. Our medical device EMC services include stringent tests to the international IEC 60601-1-2 standard to ensure adequate electromagnetic safety, performance and effectiveness of your medical devices and equipment for rapid global market access.

Our EMC laboratories have various accreditations and approvals, including ISO / IEC 2: 17025, ISO 2005: 9001 certification, National Certification Agency (NCB) and Certification Agency Test Laboratory (CBTL) issued by NVLAP, A2008LA or UKAS.

Our Medical Device testing and certification services

• Medical Device Battery Test
• Microbiological Analysis
• EMC Test
• Product Safety Test
• Radio and Wireless Tests
• Environmental Tests
• International IECEE CB certification
• CE marking of Class I, IIa, IIb and III devices

Wireless medical device test

Many medical device manufacturers want to add wireless features to their existing products. EUROLAB helps you obtain the necessary legal approvals for your wireless medical devices.

We can integrate many technologies into our medical device test, some of the applications we work with; MedRadio, Wireless Medical Telemetry, RFID and Wi-Fi®, Bluetooth® and GSMTM radio applications.

When wireless functionality is added to a wireless device, wireless cohabitation assessments become an essential part of providing basic performance and basic security. EUROLAB has developed a series of test packages to assist and test these issues.

Harmonized standards for medical devices

• EN / IEC 60601 series
• ANSI C63.27 on wireless coexistence
• AIM 7351731 on RFID evaluation
• US FDA 510 (k)
• Medical Device Directive (MDD)
• Expert regulatory team to provide support and guidance, including ISO 14971 risk management

With our deep knowledge of international standards, regulatory expertise and access to a global lab network, EUROLAB can harmonize different testing requirements for regulatory presentations and other key certifications to meet your testing needs, wherever it will be sold worldwide.

You can reduce your time to market

From product design to prototype evaluation, testing and full compliance and certification, our medical regulatory specialists work with you to determine the appropriate requirements for your specific medical device.

This helps eliminate both the cost and risk of medicinal product validation and validation during the official testing phase, and as a result, quickly delivers your products to the market.