ABSTRACT
Broad use of harmonized, globally agreed technical rules— generally International Electrotechnical Commission (IEC) International Standards—helps increase the availability of safe, affordable, quality medical devices. The IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components administers third party conformity testing and certification schemes that address the safety, quality, efficiency and overall performance of components and goods that are used in the home, office, or health facilities. An International Standard and a global Conformity Assessment System is at its most effective when regulatory requirements are harmonized. Compliance regulations will heavily affect their design and manufacture, including mechanical, electrical, and software matters. Compliance regulations will heavily affect their design and manufacture, including mechanical, electrical, and software matters. However, when regulation is too severe in terms of safety or ambiguous or confusing in its requirements, it can hinder investment and with it patient access to affordable diagnosis and treatment options.
