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The term ‘medical device’ covers a vast range of products, from highly sophisticated medical equipment and systems to simple spirometers.
Medical devices are heavily regulated due to the type of environment in which they are used and the potential severity of product failure. They must not interfere with, or be affected by, other devices in the environment so as not to compromise the clinical condition of safety of users or patients.
Cranage EMC and Safety can support you in achieving compliance for the medical standards IEC/EN 60601-1, IEC/EN 60601-1-2 and IEC/EN 61010-2-101, which are used in countries worldwide. We specialise in the assessment of Class 1, 2a and 2b medical electrical equipment with type B, BF and CF applied parts.
We have experience of evaluating electrical equipment intended to be used in the diagnosis, treatment or monitoring of a patient, or for compensation or alleviation of disease, injury or disability. Our engineers work with customers to get their medical devices compliant for the country in which they will be used, whether this is CE marking in Europe or a country specific equivalent.
We have a vast portfolio of medical items previously tested, some examples of which are:
-lifting devices
-prosthetic limbs
-patient monitors
-pulse oximetry
-hospital beds
-ultrasound devices
-blood pressure monitors
-TENS machines
Get in touch with our team to discuss your requirements for Medical device testing
For more information on Cranage EMC and Safety Medical Device Testing talk to Cranage EMC & Safety
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