What role does the International Organization for Standardization (ISO) play in MedTech?

The International Organization for Standardization (ISO) plays a crucial role in the medical technology sector by developing international standards for medical devices. These standards are designed to ensure safety, quality, and efficiency in the design, manufacturing, and use of medical devices globally. By establishing a uniform set of criteria, the ISO helps facilitate international trade, enhances product quality, and protects public health, fostering greater confidence in medical technologies among consumers and healthcare providers.

In contrast to other options, ISO does not engage in the regulation of pricing for medical devices, as that responsibility typically falls under national regulatory bodies. Furthermore, while it does not conduct clinical trials, those studies are usually performed by manufacturers or independent research organizations to assess product efficacy and safety. Lastly, the organization does not provide certifications for healthcare professionals; instead, certification of individuals is usually managed by specific professional bodies or associations. Thus, the primary function of ISO in the MedTech field is rightly recognized in the development of international standards.