Software Regulated as a Medical Device

07 Mar 2011

Intertek Medical Minute
Medical devices have most commonly been used as a tool or apparatus to help treat an illness, or are used as part of a therapeutic regimen. But as the medical device manufacturing world meets the increased demands of the patient/provider world, there is a higher demand for medical device software – specifically, software to capture or acquire data from a medical device for aiding directly in diagnosis or treatment of a patient.

Depending on their intended use, some types of software were always considered medical devices by regulators of the medical device industry around the world; but this was widely misunderstood. Regulators have attempted to eliminate the misunderstanding by putting their expectations in writing and educating the market. Consequently, developers of software that is now considered a medical device must quickly become compliant to applicable regulations for placing these devices on the market and – in some cases – work with third-party certification bodies to obtain quality management system certification.

But what is the impact of these regulations, and what do developers of software that is considered a medical device need to know now? Learn more about specific regulations in the March 21 blog.

In the meantime, to learn more about regulations as they relate to medical devices or to speak with an Intertek expert on this subject matter, e-mail us at askmedical@intertek.com.