Medical device regulations

What is bioburden and how can it be controlled?

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...

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The 12 phases of medical device development

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,...

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Medical device labelling – how to get it right

Medical device labelling – how to get it right

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...

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Are you ready for the new Medical Device Regulation?

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...

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Medical device packaging – how to get it right

Medical device packaging – how to get it right

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...

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