EUROLABWith its expert team and state-of-the-art laboratories, it provides medical device testing, certification and evaluation services for global product approvals. It offers the most comprehensive services for medical device testing, certification and global market access.

What is Medical Device Test?

Medical device testing consists of a series of safety and EMC tests to confirm that a product will not interfere with the applicable medical environment and avoid unacceptable risks to patients.

A risk assessment is also carried out by the manufacturer and submitted to a test laboratory in the form of a risk management document. This document proves that a manufacturer has assessed all potential hazards and reduced the associated risks to the greatest possible extent. General test requirements for most electronic medical devices can be found in the IEC 60601 standard family.

The medical industry is rapidly adopting new technology that enables better communication and performance of products and systems to increase patient safety. Electronic devices used in medical settings have important safety and performance requirements not only to ensure safety and compatibility with other critical care equipment, but also to reduce unacceptable risk to patients. As a result, medical device regulations constantly confront manufacturers with a number of compliance challenges.

EUROLABProvides the most comprehensive services for electrical product safety, electromagnetic compatibility (EMC), RFID sensitivity, and FDA submissions for medical devices to verify compliance with major standards including 60601, ISO 14708, and international regulations.

Medical Device Testing Services

With product safety and electromagnetic compatibility expertise EUROLAB Within the scope of Medical Device Testing, we help solve the complexities of medical device compatibility on your behalf. From testing and certification to global market access, we help you bring your product to market faster and more cost-effectively.

As part of the global test network, we can provide an end-to-end solution to all your testing and compliance challenges.

• Medical Device Safety Test
  
• IEC 60601-1
• Medical Device EMC Test
• FDA Submissions
• Laser Safety Test
• Battery Testing and Certification

Leader in Medical Device Tests

EUROLAB, NRTL is a laboratory and officially recognized mark by OSHA for workplace safety. As a trusted partner in the industry, we offer regulatory compliance expertise and experienced ISO 17025 testing to ensure fast turnaround times with the highest level of service for active medical devices / electrical equipment.

Single Source for Medical Device Certificates

We offer a full range of medical device product safety testing for the 60601-1 family of standards. We also offer complete tests for active implantable devices. Our modern 3, 5 and 10 meter EMC rooms are equipped to evaluate your medical device according to global EMC and Wireless regulation requirements. Our FDA shipping services ensure your shipping meets FDA requirements and your product launch is not delayed.

Testing and Certification for Worldwide Market Access

We can provide testing and technical reports that can be used to support the manufacturer's Declaration of Conformity (DoC) for CE marking. EUROLAB Along with Medical Device Testing, we work with product designers and manufacturers to certify products under the various annexes of the Medical Device Directive (MDD). EUROLAB's Notified Bodies are authorized to issue Type Certificates for active and inactive medical devices in accordance with the Medical Device Directive.

Our Medical Device Testing and Certification Capabilities 

Our comprehensive knowledge of industry performance and national safety standards and extensive global testing and certification resources enables fast and cost-effective market entry.

• Product Safety Testing and Certification of Active Medical Devices 
• Electromagnetic Compatibility (EMC) of Active Medical Devices 
• Laser Safety Test of Medical Laser Products According to IEC 60601-2-22 
• FDA Submissions 
• Battery Safety Testing of All Battery Chemistry Used to Power Medical Equipment 
• RFID Sensitivity of Active Medical Devices 
• Certification Body (NCB) and Certification Body Test Laboratory (CBTL) certification for Medical Electrical products 
• Examination of high-tech medical devices (eg MRI and CT scanners) in hospitals 

EUROLAB, with its highly expert team and internationally accredited laboratories, Medical Device Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.