Services for the Medical Device Industry

From our modern and fully equipped, UKAS accredited laboratories, TRaC deliver a complete portfolio of services for medical devices and associated equipment, including Radio, EMC, Safety and Environmental testing to national and international product standards. In addition to this, the TRaC Approvals team can provide complete project and compliance management for truly worldwide market access.

TRaC is the only test lab in the world that can perform testing for Bluetooth Qualification and ZigBee Certification, two of the leading technologies employed in medical device communication.

Related services

Environmental Testing and Analysis

Medical devices and equipment generally operate within a benign environment, however, in today’s global market, the ability of a product to withstand various extremes of transportation and storage conditions is critical to it’s success. TRaC can offer a wide range of vibration and shock testing of medical products to simulate transport by rail, road, sea and air. TRaC also offer a wide variety of climatic conditions, from high and low temperature, altitude and humidity, to ingress protection and salt corrosion to represent the wide range of storage environments your product may encounter before going into service. In addition to providing controlled test environments, TRaC can also simulate the mechanical environment using Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) computer modeling techniques.

Typical standards tested to include:

Radio testing

Medical devices are increasingly relying on radio technology to communicate and the Continua Health Alliance has defined ZigBee and Bluetooth as the technologies of choice for these devices. TRaC are the only company in the world to offer certification, qualification and regulatory for both Bluetooth and ZigBee devices.

Telecoms testing

Medical devices that collect information such as Blood Pressure, or insulin levels and pass the information back to a central database may do so via an information portal. These portals tend to utilize xDSL technology and TRaC is the premier laboratory to provide this testing, with two dedicated DSL labs to provide a complete DSL test service.

EMC Testing

Medical equipment is an area of electronics that covers a wide variety of equipment. All medical products are ultimately tested to CISPR11 however there is a dedicated medical standard (IEC60601-1-2) which details what limits from CISPR11 should be applied.

Typical standards tested to include:

Test reports

Medical test reporting requires a very professional approach with careful attention to detail as laid down in the test standards. These reports are more involved than most "commercial" reports because of the nature of complex equipment under test. At TRaC we acknowledge the requirement for speedily generated test reports. Under normal circumstances reports are generated within two weeks. However we do offer a report generation service within 2-3 days if required.

Benefits of testing at TRaC

Through our national, international and industry-specific approvals, your qualification testing and assessment at TRaC provides your product with a passport for global market access. TRaC have unrivalled technical capabilities, competences and track record in delivering demanding qualification and compliance programmes across the spectrum of industry. Our expertise is not limited to testing, and we are available to de-risk your qualification process throughout your product lifecycle, from bid support, design analysis, and pre-compliance testing, saving our customers time and money. We provide our clients with one-stop access to the complete approvals process, with dedicated project managers delivering a single-point-of-contact turnkey service.  With a comprehensive range of test facilities, state-of-the-art equipment, automated test processes and flexible shift patterns, TRaC deliver the highest levels of test efficiency and scheduling to meet the most demanding qualification deadlines.