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…
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 the lowest possible…
The difference between ethylene oxide and gamma sterilization
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) sterilization. Gamma sterilization and…
5 steps to protecting intellectual property in medical device development
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 outsourcing medical product manufacturing, it is vital to choose a…
The 12 phases of medical device development
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,…
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 or…
A guide to RF welding in medical device manufacturing
Radio frequency welding, or RF welding as it is more commonly known, is a key medical device manufacturing process. It has a direct impact on product and packaging quality and performance. RF welding is the process of fusing materials together…
The benefits of working with a specialist medical device manufacturer
When you outsource your medical device manufacturing, it is crucial that you choose the right partner – one that you can trust and that will make your business stronger. It’s a critical choice. The decision that you make will have…
The advantages of a full-service contract medical device manufacturer
When deciding to outsource your medical device production, it is important to know what your options are and that includes assessing the benefits that working with a full-service contract medical device manufacturer could offer you. The choice as to whether…
Are you ready for the new Medical Device Regulation?
The new European Medical Device Regulation (MDR) comes into force on 26th May, bringing with it the most radical overhaul of the medical device regulatory framework that the medical device industry has seen in decades. The primary objective of the…