Does the machine need to be medical grade?

A good machine with the standard household CE marking is not good enough. For great machines, it has to prove that it is medical grade certified. It has to go through vigorous testing and able to demonstrate that the specifications and results are genuine.

Medical grade machines do not mean that the user has to have a medical background to use it, only some countries apply.

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

Does the seller’s facility need to demonstrate a medical standard?

Having a medical grade machine means nothing if your system is being serviced or repaired by a non-medical registered factory. It can actually make the system worse.

Always check the address on the ISO:13485 certificate to validate the registered certified location. Sellers can advertise this logo but it does not mean that their own facility is certified. Safety and quality are non-negotiable in the medical devices industry.

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. This can also void the medical grade machine standard.

AW3 is ISO 13485:2016 certified. This means that our facility is involved in the design, production, installation and servicing of medical devices and related services.

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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