Internet of Medical Things (IoMT)

We specialize in guiding manufacturers of IoMT devices through the intricate regulatory landscape, ensuring secure, compliant, and reliable products for global markets.

Our solutions address the unique challenges of connected medical devices under MDR 2017/745, offering support at every stage of development.

Wireless Connectivity Compliance: Assisting with Bluetooth, Wi-Fi, and other wireless communication testing to meet international standards.
Cybersecurity for IoMT Devices: Ensuring compliance with data security regulations such as GDPR.
Interoperability Testing: Validating that your IoMT devices seamlessly communicate with other systems within healthcare networks.
MDR Compliance: Offering tailored guidance on meeting regulatory requirements for connected medical devices in the EU.
Risk Management for IoMT: Supporting compliance with ISO 14971, focusing on the specific risks posed by networked medical devices.
Technical Documentation: Preparing comprehensive documentation for IoMT products, including clinical evaluations, software validation, and cybersecurity assessments.

By addressing the critical aspects of IoMT compliance, we help you bring safe, innovative, and connected medical devices to market efficiently and confidently.

Contact us today for more information!

Have questions? Reach out today for a personalized consultation about your specific IoMT device and how we can assist.

How we helped our client with Internet of Medical Things (IoMT)

Challenge

Rapid Response Revival, an Australian MedTech innovator, developed the world’s smallest, fully portable AED — no bigger than a chocolate bar, designed to fit easily in a backpack. Despite the breakthrough design, the company faced regulatory hurdles: Compliance with the Radio Equipment Directive (RED 2014/53/EU) and Medical Device Directive (MDD) was required for EU market entry. The new Medical Device Regulation (MDR 2017/745) was about to come into force, leaving little time to update the device design. Without timely certification, there was a real risk of delayed approvals and missed market opportunities. To overcome these challenges, Rapid Response Revival turned to IoT Consulting Partners for expert guidance and fast-track compliance support.

Outcome

Through close cooperation, leveraging our global regulatory networks and extensive experience in compliance, IoT Consulting Partners: Guided Rapid Response Revival through the complex requirements of RED and MDD. Developed a streamlined pathway to achieve timely approvals before the MDR deadline. Ensured the AED was fully compliant with both Radio and Medical Device regulations, avoiding costly redesigns and market delays. As a result, Rapid Response Revival successfully launched their groundbreaking AED in international markets — safe, compliant, and market-ready — cementing their position as a true innovator in the Internet of Medical Things (IoMT) sector.

Essential requirements under the RED (2014/53/EU) and the standards that ensure compliance:

Note: For conformity assessment under the RED (2014/53/EU) and related directives, the *latest versions of harmonized standards* as published in the Official Journal of the European Union (OJEU) shall always be applied.

Article 3.2 Radio; efficient use of the radio spectrum.

Standard	Description	Technology / Devices
EN 300 220	Short Range Devices (SRD) operating in the frequency range 25 MHz to 1 000 MHz	Short Range Devices (e.g. 434 MHz, 868 MHz)
EN 300 328	Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band	Bluetooth, Bluetooth Low Energy, WLAN, Zigbee, Kleer etc.
EN 300 330	Short Range Devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz	Short Range Devices (e.g. Immobilizer, NFC...)
EN 300 440	Short Range Devices (SRD); Radio equipment to be used in the 1 GHz to 40 GHz frequency range	Short Range Devices, WLAN 5 GHz (Band 4)
EN 301 091	Short Range Devices; Transport and Traffic Telematics (TTT); Radar equipment operating in the 76 GHz to 77 GHz range	76/77 GHz Radar Devices
EN 301 511	Global System for Mobile communications (GSM); Mobile Stations (MS) equipment	GSM Devices (e.g. Mobile Phones, Cellular)
EN 301 893	5 GHz RLAN	WLAN 5 GHz (Band 1-3)
EN 301 908-1	IMT cellular networks	3G / LTE Devices (e.g. Mobile Phones, Cellular)
EN 302 065	Short Range Devices (SRD) using Ultra Wide Band technology (UWB)	UWB Devices (UWB location tracking / UWB devices for ground based vehicular applications)
EN 302 208	Radio Frequency Identification Equipment operating in the band 865 MHz to 868 MHz with power levels up to 2 W and in the band 915 MHz to 921 MHz with power levels up to 4 W	RFID Devices
EN 302 264	Short Range Radar equipment operating in the 77 GHz to 81 GHz band	Short Range Devices / Road Transport and Traffic Telematics (RTTT) / Short Range Radar equipment
EN 302 372	Short Range Devices (SRD); Tank Level Probing Radar (TLPR) equipment operating in the frequency ranges 4,5 GHz to 7 GHz, 8,5 GHz to 10,6 GHz, 24,05 GHz to 27 GHz, 57 GHz to 64 GHz, 75 GHz to 85 GHz	Tank Level Probing Radar (TLPR)
EN 302 729	Short Range Devices (SRD); Level Probing Radar (LPR) equipment operating in the frequency ranges 6 GHz to 8,5 GHz, 24,05 GHz to 26,5 GHz, 57 GHz to 64 GHz, 75 GHz to 85 GHz	Level Probing Radar (LPR)
EN 302 852	Road Transport and Traffic Telematics (RTTT); Automotive radar equipment operating in the 24,05 GHz up to 24,25 GHz or 24,50 GHz frequency range	24 GHz Automotive Radar Equipment
EN 302 858	Short Range Devices; Transport and Traffic Telematics (TTT); Radar equipment operating in the 24,05 GHz to 24,25 GHz or 24,05 GHz to 24,50 GHz range	24 GHz Radar Devices
EN 303 345	Broadcast Sound Receivers	Broadcast Sound Receivers (AM/FM/DAB/DRM)
EN 303 406	Short Range Devices (SRD); Social Alarms Equipment operating in the frequency range 25 MHz to 1 000 MHz	Short Range Devices (SRD); Social Alarms Systems
EN 303 413	Satellite Earth Stations and Systems (SES); Global Navigation Satellite System (GNSS) receivers; Radio equipment operating in the 1 164 MHz to 1 300 MHz and 1 559 MHz to 1 610 MHz frequency bands	GNSS Receivers (GPS, BeiDou, GLONASS, SBAS)
EN 303 417	Wireless power transmission using technologies other than radio frequency beam in the 19-21 kHz, 59-61 kHz, 79-90 kHz, 100-300 kHz, 6765-6795 kHz ranges	Wireless Chargers
EN 305 550	Short Range Devices (SRD); Radio equipment to be used in the 40 GHz to 246 GHz frequency range	Ultra Wide Band (UWB)

Article 3.1(b) EMC; Adequate level of electromagnetic compatibility.

Standard	Description	Technology / Devices
EN 301 489-1	Part 1: Common technical requirements	-
EN 301 489-2	Part 2: Specific conditions for radio paging equipment	Paging Devices
EN 301 489-3	Part 3: Specific conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz and 246 GHz	Short Range Devices
EN 301 489-17	Part 17: Specific conditions for Broadband Data Transmission Systems	Bluetooth, Bluetooth Low Energy, WLAN, Zigbee, Kleer etc.
EN 301 489-19	Part 19: Specific conditions for Receive Only Mobile Earth Stations (ROMES) operating in the 1,5 GHz band providing data communications and GNSS receivers operating in the RNS	GNSS Receivers (GPS, BeiDou, GLONASS, SBAS)
EN 301 489-33	Part 33: Specific conditions for Ultra-WideBand (UWB) devices	Ultra Wide Band (UWB)
EN 301 489-51	Part 51: Specific conditions for Automotive, Ground based Vehicles and Surveillance Radar Devices using 24,05 GHz to 24,25 GHz, 24,05 GHz to 24,5 GHz, 76 GHz to 77 GHz and 77 GHz to 81 GHz	Radar Devices
EN 301 489-52	Part 52: Specific conditions for Cellular Communication User Equipment (UE) radio and ancillary equipment	Cellular Devices (GSM/UMTS/LTE)
EN 55032	Electromagnetic compatibility of multimedia equipment – Emission requirements	Multimedia Equipment, Broadcast Receivers
EN 55035	Electromagnetic compatibility of multimedia equipment — Immunity Requirements	Multimedia Equipment, Broadcast Receivers

Article 3.1(a) Health and Safety; Health and safety of persons and of domestic animals / safety requirements.

Standard	Description	Technology / Devices
EN 62368-1	Audio/video, information and communication technology equipment Part 1: Safety requirements	All Radio Devices
EN 62311	Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz to 300 GHz)	All Radio Devices with an output power above the low-power exclusion limit
EN 62479	Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic fields (10 MHz to 300 GHz)	Radio Devices with an output power below 20 mW (low-power exclusion)