Wireless Medical Devices Overseas Program
Time:2022-06-13
Views:1185
New global spread of the epidemic, to some extent, to speed up the Chinese medical device products to sea, medical equipment as the most regulatory products, is related to people‘s health and safety, in addition to conventional clinical and medical function of the FDA and CE-MDR / MDD certification, there are other key about electronic wireless this test certification.
In addition to the sensors used to monitor and detect human biological indications, blood oxygen, blood pressure, blood sugar and so on, medical devices also have a series of communication systems for transmitting these data. used to transmit the monitored data to the cloud or database or background monitoring center.
A medical device product will carry a common wide-area wireless 2G/3G/4G/5G, including the now popular Internet of things 4G communication standards such as Cat.M (eMTC) / NB-IOT.
WI-FI and Bluetooth are common in local area wireless. For products with wide area wireless 2G/3G/4G/5G, it is necessary to access the network of operators in foreign countries, and the acquisition of stable, secure and continuous wireless resources is particularly critical. These resources eventually point to foreign telecom operators, so medical device products with wide area wireless need to be certified by telecom operators.
The certification of operators is not one or two separate certifications, but a series of certifications. One link is fastened to meet the certification requirements of the operator. For example, the series certifications of medical device products with 2G hand 4G + Bluetooth / WI-FI are as follows.
Basic legal certification, FCC ID,IC ID,DOE,DOC,Ca 65, etc.
The test contents include: radio frequency test, human radiation absorption SAR test, electromagnetic compatibility EMC test, lithium battery energy efficiency test, electronic product toxic substance test.
Technical alliance certification, Bluetooth SIG certification, WI-FI alliance certification.
The test involves: receiver-transmitter RF signal evaluation (different from legal RF test, evaluation in more detail), functional configuration test, throughput test, encryption security test, interoperability conformance test, etc.
Operator alliance certification, PTCRB/GCF certification.
The test content involves: radio frequency consistency, communication protocol consistency, field test verification, air radiation performance test, card interface test, function test (such as short message, VoLTE,VoNR) and so on.
Operator certification, T-mobile/Verizon/AT&T certification
The test contents include: network interconnection and interworking test, real network test, air port radiation assessment, network security verification, functional stack test, equipment software evaluation, firmware upgrade test and so on.
This series of test certification takes a long time, many technical documentation requirements, difficult, the whole project to do a short 1-2 months, long takes half a year, so it is best to start to prepare the relevant test certification after the completion of the product design. From the determination of the communication system in the early stage, to the screening of the frequency band, etc., if problems are found in the testing process, the problems will be improved in time, and then retested.
To apply for the operator T-mobile / Verizon / AT & T certification, you need to have PTCRB / GCF certification in advance, and then enter the test certification of the operator. However, to obtain the PTCRB authentication ID number, you need to prepare ICID, FCC ID, WI-FIC ID alliance and other certification in advance, and formulate the ID number of the product to submit.
When the product is submitted to the operator, it needs to pay attention to the software version number and hardware version number of the product. When using the certified communication module, it needs to give the accurate firmware number and ensure that the module is effective.
Deeplight has assisted a number of well-known medical device manufacturers to complete the wireless outbound plan, especially in the North American market, in the early stage we can provide customers with product certification plan, testing time, certification projects, we can integrate a variety of testing advantages to provide a complete set of service solutions.
In addition, it can assist customers to choose the communication system and communication frequency band. Assist customers in selecting available modules, ensure the validity date of modules, the type of module, module is in the operator certification list, speed up the time to market of customer products. Customers are welcome to consult us!
+86-13266518903
