Medical Device Quality Control

THAY Medical currently quality check medical devices for customers who wish an extra level of compliance and confidence with their production and manufacturing. We do this service to generate extra data on each medical device before it is reaches the user. This data supports the device master record or batch record for each device where it may be lacking beforehand. This is common with products made in more economic areas of the world, or where products have required rework to meet country specific requirements.

Increasingly the “out of the box” experience by the user is a human factors engineering requirement – to ensure this user experience is positive. This follows in the steps of the consumer industries where we expect a positive experience when opening a new product for the first time and each subsequent time, prior to use. Medical devices should have the same level of positive user experience, and by ensuring that production of a device is consistent, with supporting data to prove it, then this positive user experience can be present each and every time for every medical device.

A frequent production-based risk is that there are missing or defective components. By adding a Quality Control element to the production process, the risk can be minimised and proven through data generated by a Quality Control process – defective components and whether every component is present can be checked and documented. Even if a User Manual or a plug adaptor is missing from a medical device, the user may not be able to use the device safely when they come to want to use it. For any medical device manufacturer this will be a worry until data proves otherwise, and here at THAY Medical, we offer this service to assist with generating confidence in the production of your medical devices.

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