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Smart Medical Devices

Tested and certified smart medical devices for state-of-the-art healthcare

Medical devices using IoT wireless technology are revolutionizing healthcare. Smart devices such as wearables now link patients to doctors, transmitting critical medical data in real time from hospital beds and private homes as well as mobile equipment used at emergency sites and in transport vehicles. Wireless devices implanted in the body permit patients to be continuously monitored to alert health care providers of changes that may require necessary action. Smart personal medical devices allow patients unprecedented mobility while providing clinicians real-time data to ensure patients the highest level of care. Smart medical devices are held to strict regulations and must be tested and certified according to established requirements such as FCC in the US markets and RED compliance for the EU market.

We provide comprehensive testing services to meet various regulatory requirements designed to certify the quality, compliance, reliability, and safety of your smart medical devices. Our experts conduct interoperability and performance testing to ensure the electromagnetic compatibility, cyber security, and functional safety of smart devices to be used in the modern healthcare industry. We test the compatibility of your products with multiple short- and long-range connectivity technologies used to connect essential equipment and transfer critical data. Our global network of experts is on the ground around the world to provide you the localized support and testing expertise you need to successfully launch your smart medical device in the markets of your choice. We are a designated notified body in the European Union for various directives including Radio Equipment Directive (RED) along medical device Regulations (MDR), FCC TCB for the US market. Our experts and global lab network can offer comprehensive regulatory services for various medical devices.

Certified smart medical devices for fast access to any market

Our services have been developed to ensure the compliance, performance, and safety of your smart IoT medical devices. We test and certify your products according to recognized interoperability, security, and safety standards. We conduct accredited services for diverse international approvals according to established network protocols. We help you understand the technical requirements relevant to your smart medical devices and provide you reliable expert support throughout your certification process. We are able to serve you at anytime, anywhere in the world from a single source with our Market Access Services

Smart medical device testing and certification

We conduct comprehensive testing and certification for wireless smart IoT medical devices. We provide the expert interoperability, security, safety, and performance assessments you need to attain type and network operator approvals. Our experts are well-versed in the rules and regulations governing country-specific as well as internationally recognized type approvals and certification processes to ensure your successful entry to the markets of your choice.

Our services for smart medical devices include:


We are accredited to provide testing services for connectivity technologies including but not limited to LoRa®, Zigbee®, Thread®, Wi-Fi®, Sigfox®, Bluetooth®, OCF, Wi-SUN®, and OpenADR.

Wireless technology programs used to connect essential IoT devices and transfer critical data include:

  • Wi-Fi – 802.11b/g/n monitors patient vital signs, blood pressure, electrocardiogram etc. on either a hospital or home network
  • Bluetooth – Retrieves patient data on handheld bedside devices and integrates key medical equipment in hospital rooms
  • WMTS (Wireless Medical Telemetry Service) – Transfers data from body sensors with remote monitoring systems, operating in 600 to 1432 MHz frequency bands
  • MICS (Medical Implant Communication System) – Low-power, short-range, high-data-range communication supporting diagnostic or therapeutic functions associated with medical implant devices and nearby controllers, operating at 401 to 406 MHz
  • UWB (Ultra-Wide Band) – Uses low-power consumption to achieve high bandwidth connections for medical telemetry and imaging
  • RFID (Radio Frequency Identification) – RFID tags are used in hospitals to continuously track equipment, patients, and doctors, and to properly monitor hospital supply stocks
  • Zigbee – Monitors chronic disease, personal wellness, and personal fitness with low-power connectivity of a large number of devices into a single network as well as the development of the ZigBee Health Care for point-of-care medical device communication

Our comprehensive security assessment services provide a high level of assurance. We conduct hazard analyses to identify vulnerable design intersections in the device architecture. Our specialists evaluate components, data flow, and other architectural documents for potential weaknesses. We analyze source codes and conduct penetration as well as dynamic testing. We look forward to serving you.

Programs used to connect essential equipment and transfer critical data. | TÜV Rheinland

Your trusted partner for smart medical devices services

Our services are designed to provide you the expertise you need when testing your smart IoT medical devices for approvals and certifications needed to access diverse global markets. We hold international accreditations recognized around the world, and are uniquely positioned to support you in any regulatory framework. Our experts provide comprehensive services tailored to your needs from a single source. We are at your side to guide you through every process to ensure your smart medical devices are reliable, compliant and safe.

Frequently Asked Questions

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What is smart healthcare?

Smart healthcare uses IoT technology to support mobile and wearable devices that can monitor and transmit patient information for real-time response to ensure a high level of health care.

What is a smart medical device?

Equipped with wireless IoT technology able to monitor and transmit critical data in real time, a smart medical device links doctors with patients at home or en route to the hospital. These devices provide patients a high level of mobility and healthcare providers the ability to remotely monitor patient status.

Am I obligated to test and certify my device?

Yes. We provide you the appropriate testing and certifications for your particular medical device according to relevant regulations and standards.

Can you assist me in accessing new markets?

Yes. Our Market Access Services help you to successfully enter the markets of your choice. We provide you localized support on the ground around the world to launch your smart medical device into any market.

Learn more about how you can benefit from our services!

Our experts are happy to assist you with any further questions, specific needs and requests.

Wi-Fi Testing and Certification

Wi-Fi certification by TÜV Rheinland

We provide Wi-Fi testing and certification for wireless products sold around the world.

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Bluetooth® Qualification Services

Bluetooth® testing – TÜV Rheinland

We provide qualification services for Bluetooth® compatible devices to ensure quality products operate safely and reliably.

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Zigbee Testing and Certification

Zigbee testing and certification services – TÜV Rheinland

We test and certify products for automated smart systems supported by Zigbee technology.

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Thread Testing and Certification

Thread testing and certification – TÜV Rheinland

We provide Thread testing and certification services to ensure interoperability and compliance in your smart home devices.

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Wi-SUN Testing Service

Wi-SUN testing service | TÜV Rheinland

We are a Wi-SUN approved test lab for PHY (physical) layer and Field Area Network (FAN) profile according to Wi-SUN alliance specifications.

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LoRa Alliance Certification Program

LoRa Alliance Certification by TÜV Rheinland

We test and certify your LoRaWAN devices according to the requirements and specifications of the LoRa Alliance.

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Regulatory

CE | FCC/ISED | Japan Radio Law | Korean Radio Law | Anatel | Taiwan | etc.

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Wireless Industry Certification

Wi-Fi | Bluetooth SIG | Thread | Zigbee | LoRaWAN | Sigfox | Wi-SUN | OpenADR | Econet | KNX | Dali | GCF | PTCRB | Mirrorlink

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Cyber Security

Managed Security | Penetration Testing | ICS Security | Cyber Security in Industrial Automation

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