FDA Medi Grade ISO TradeMk


Does the machine need to be MDR?

This is the new legal standard of Medical Grade and as of 26th May 2021 all machine sales and use in Europe and the UK are required to be Medical Directive Regulation approved. Before committing to a purchase, ask the seller to confirm in writing that the actual machine is “MDR“. A good machine with the standard household CE marking is not good enough. For great machines, it has to prove that it is MDR medical grade. It has to go through vigorous testing and able to demonstrate that the specifications and results are genuine.

There are 2 types of Medical grade standards and they are not to be mixed up. The old MDD standard will eventually be phased out and the new MDR standard is here to stay. Using an MDR machine does not mean that the user has to have a medical background to use it, only some countries apply.

The majority of our systems are MDR Medical Grade registered and U.S FDA cleared. The quality of an MDR system produces far better results, safety and compliance than a non MDR system.


For more information regarding MDR regulation

Read full facts here

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What is ISO:13485 verified supplier?

This means that the facility is involved in the design, production, installation or servicing of medical devices and related devices. This still does not guarantee that the actual machine is MDR. Always ask sellers to confirm in writing that the machine is MDR as this is more important to machine owners. Having an ISO 13485:2016 is rather related to the quality of the supplier’s management rather than the quality of the actual machine itself, so please don’t mix this up and end up buying a non MDR device.

At AW3, you have a peace of mind knowing that your future machine is being serviced, repair and supported at a medical equipment registered facility. This set your system apart in quality assurance compared to a unregistered location with basic tools and knowledge.

As an ISO 13485:2016 certified manufacturer, our state of the art facility must be able to demonstrate our quality management processes and ensure best practice in everything we do, in order to meet this highly regulated standard.

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