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