The market for medical devices - which covers a very wide range of products, from bandages to artificial hearts - represents a substantial global business, worth over £200bn per year and growing rapidly. For obvious safety reasons, sales of medical devices are highly regulated and gaining approval for their sale and distribution can be a lengthy and complex process. In this context, BSI has spent recent years forging links with regulators around the world, with a view to improving understanding and communication between manufacturers, regulators and healthcare authorities, and ensuring greater harmonization across the industry.
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