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...
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 a year it has been for everyone. As we look back on 2021, we’ve taken the opportunity to reflect on some of the highlights and events of the last 12 months that have made it a year to remember for all the right reasons. We have seen a...
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...
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)...
In a marketplace characterised by increased globalisation, fast-paced innovation, fierce competition and stringent regulation, the protection of product intellectual property is a key priority for medical device companies. Therefore, when...