ABSTRACT
Today, electronics and electrical, including medical devices, are more similar than ever before. Broad use of harmonized, globally agreed technical rules—generally IEC International Standards—helps increase the availability of safe, affordable, quality medical devices. While the trade of medical electrical equipment is global, the regulatory environment is still local to each specific jurisdiction. Medical electrotechnical equipment is of increasing importance in areas that were traditionally covered by non-electrical medical equipment. Growing demand can have a positive impact on cost and innovation, if manufacturers are able to access large markets that allow them to off-set often high development costs. All medical devices need to meet a rather complicated set of safety requirements. Compliance regulations will heavily affect their design and manufacture, including mechanical, electrical, and software matters.
