Medical devices
Before a medical device can be put onto the market, the safety of the product has to be demonstrated through a variety of tests, the last round of which, termed "clinical investigations", is carried out on humans. Both ethical and safety considerations have to be taken into account during such investigations and they are very costly. Standardizing the requirements for these investigations at the international level so that the results achieved in one country are accepted in others can cut the costs of development. It can also speed up the introduction of medical devices around the world and so bring relief to suffering patients.
The international consensus, which produced ISO 14155, has been achieved by addressing and reconciling culture-sensitive ethical issues and differing national safety requirements. Like many of the challenges which ISO faces when developing International Standards, the job was difficult, but the objectives make the effort worthwhile: increasing efficiency - which has an impact on the bottom line - and improving the quality of life for people worldwide.
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