Medical devices

What are medical devices?

A medical device is any instrument used to diagnose, prevent or treat diseases and medical conditions. This means the list of medical devices is extremely long: from a simple plaster or blood pressure monitor to an MRI scanner. And with an ageing population, advances in medicine, and an increasing number of people suffering from chronic illness, this sector continues to grow.

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What advantages do medical device standards offer your company?

Legal requirements for medical products are becoming increasingly stringent. Companies that apply standards can count on many benefits:

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• The medical devices meet all safety and quality requirements.
• The products conform to CE marking and MDR2017/745.
• The standards create clarity among producers and buyers.
• The end consumer is better protected thanks to after-sales safety.

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Medical device standards by topic

There are many medical devices, so it follows that there are many medical device standards. Below, we’ve grouped them by topic for a better overview:

Standards for management systems:

The most important standard is undoubtedly ISO 13485, the certifiable quality management standard for the medical device industry. There is also a standard for risk management.

Standards for commercialisation:

There are standards to help you get your medical device on the market, such as standards for:

• provision of information by the manufacturer
• monitoring by the manufacturer after the product is on the market
• product labelling 

Standards for use of information technology:

Medical devices that use software also have standards that apply to them.

Biological applications:

Standards also help with biological evaluation of medical devices, or microbiological contamination, for example.

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