Medical images on a tablet PC

Medical Technology Testing

Medical device testing – approval of medical technology

The field of medical technology is highly diverse and innovative. The number and performance of technologies used in medical devices has evolved steadily over the years. These devices are designed for use in a variety of situations and environments – thus they are subject to numerous standards and regulations.

For successful market access, these medical devices must meet basic safety and performance requirements, which can vary widely by market. That’s why we support our medical industry customers with various services regarding medical device testing and approval procedures. We enable the certification of their medical devices as well as their successful market launch.

Accredited testing of medical devices - Certification of medical technology

With individually tailored consulting, testing and certification solutions, we ensure that medical devices meet the quality, health, environmental and safety standards required for market access. Our test reports are recognized worldwide and thus provide the foundation for market approval in over 180 target countries.

We hold DIN/ISO/IEC 17025 accreditation by DAkkS and are also recognized by ZLG (Central Coordination Office for Human and Veterinary Medicinal Products in Germany). With our broad testing portfolio and expertise, we enable fast and cost-effective medical device testing and approval of medical technology.

Medical device testing & approval - essential regulations & specifications

We have many years of experience regarding electrical safety and electromagnetic compatibility (EMC) testing. As a recognized test service provider, we offer the following test procedures for medical devices / medical technology:

General medical device testing:

  • Medical Device Regulation 2017/745 (MDR)
  • Regulation 2017/746 on in vitro diagnostic medical devices (IVDR).

Electrical safety testing of medical devices:

  • EN/IEC 60601-1 / -1-8 / -1-11 and EN/IEC 61010-2-66 including required technical documentation such as
    risk management (ISO 14791), usability (EN/IEC 60601-1-6), software documentation (EN 62304)
  • EN/IEC 61010-1
  • EN/IEC 61010-2-040 / -081 / -101
  • IEC 61010-031

EMC testing of medical devices:

  • EN/IEC 60601-1-2
  • EN/IEC 60118-13
  • EN/IEC 61326-2-6

In addition, we are an accredited test laboratory for the CB scheme (CB Report) in electrical safety and EMC. As a Partner Test Laboratory (PTL) we can also provide NRTL certifications through our network.

Tests for medical devices with wireless technologies

Medical devices that use wireless radio technologies, such as Bluetooth®, Wi-Fi, DECT, radar or NFC must meet the requirements of both the Medical Device Directive and the Radio Equipment Directive (2014/53/EU) in Europe.

The European Union’s Radio Equipment Directive (RED; replaced R&TTE in 2014) applies to electrical and electronic equipment that intentionally emits and/or receives radio waves. Medical devices with radio technologies thus also fall into this category.

Our testing services cover all common radio technologies according to current norms and standards. Thus, we can provide medical device testing services as well as the certification of medical technology to enable an early approval on the market.

Further services for medical technology products

In addition to regulatory testing and certification services, we also offer many other services for medical devices. These include: