Global Radio Frequency Regulations for Medical Devices

M

murena

Hi all.

Sometimes I struggle to grasp the regulatory requirements for devices that have some kind of wireless communication capability. Normally, those regulations are managed by non-medical device agencies (e.g. FCC in the US), and the requirements are too technical or confusing.

Does anyone know of a good summary or introduction to the regulory requirements for radio frequency approvals or a training course?

My perception is that currently many companies rely on consultants or testing houses to get the required approvals and licences, and there is very few capability being developed in-house for this topic.

Thank you.
 

Pads38

Moderator
Only a partial answer but you could try here:

https://www.compliance-club.com/

If you register (free) you can get access to the archive of the journal.

In issues 98 and 99 there were a pair of articles entitled "Bringing license free wireless products to the market in the EU" by Tim Jarvis.

The articles are not medical device specific but may give you some background.
 
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