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...
Fiona Chitty
What is bioburden and how can it be controlled?
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...
A guide to leak and block testing in medical device manufacturing
Medical leak and block testing is a critical medical device manufacturing process. This quality control measure is a safeguard against product failure and plays a key role in ensuring the safety and performance of your medical product. A blockage...
The importance of quality assurance in disposable medical device manufacture
Quality assurance is critical to all medical devices, including disposable ones. Should a manufacturer fail to provide quality assurance and a product does not function correctly, it could have increased risk to the end user. A failure to assure...