The expiry, or near expiry, of the shelf life of a medical device can be a problem for medical device manufacturers when your device is low volume with a large minimum order quantity (MOQ) or sales have not been as forecast. This situation can have...
Medical device regulations
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How is shelf-life testing of sterile medical devices performed?
15/02/2022
Shelf-life testing is a critical step in preparing a medical device for the market and is mandatory for all products. Fail to perform this testing correctly and you will likely have to recall products, and risk significant damage to your market...
What is bioburden and how can it be controlled?
09/11/2021
The ability to accurately measure and strictly control bioburden is integral to a high standard of medical device manufacturing and assembly. It is important therefore that your medical device contract manufacturer has systems in place that ensure...
The difference between ethylene oxide and gamma sterilization
14/09/2021
Medical sterilization is most often the final part of the medical device contract manufacturing process and there are various sterilization methods that can be used. The main ones are gamma (irradiation) sterilization and ethylene oxide (EtO)...
The 12 phases of medical device development
11/05/2021
A key area of medical device manufacturing is the development of new and improved medical products. Much of the development process can be outsourced to a contract medical device manufacturer but it is critical that you choose the right partner,...
12 key signs and symbols on medical devices and packaging
09/06/2020
In medical device manufacturing, a medical device’s label must clearly display the necessary information to ensure not only the safety of the end user but also legal compliance. This includes a series of key signs and symbols, which should be...
Medical device labelling – how to get it right
12/05/2020
It is critical that you get medical device labelling right. If your product is used improperly as a result of incorrect or insufficient labelling, you can be hit with significant fines, costly delays and reputational damage. In medical device...
Are you ready for the new Medical Device Regulation?
14/04/2020
The new European Medical Device Regulation (MDR) came into force on 26th May, 2020, bringing with it the most radical overhaul of the medical device regulatory framework that the medical device industry had seen in decades. The primary objective of...
Medical device packaging – how to get it right
10/03/2020
It may ultimately be destined for the bin but medical device packaging is an important aspect of a product’s design and success. As such a vital part of the product development process, any mistakes with the packaging of a medical device could...