How Voluntis Prioritizes Reducing Five Common Digital Therapeutics Risks?



At Voluntis, an Aptar Pharma company, our digital therapeutics are always designed and developed according to regulations for Software as a Medical Device set by U.S. Food and Drug Administration, European Medicines Agency, and other regulatory bodies. Within this process, our teams conduct a thorough analysis to determine all risks to a patient’s health that could result from using the medical device. The goal is to eliminate these risks, or reduce them as much as possible, to ensure that the benefits of the digital therapeutics outweigh its risks.

There are five main types of risks that our teams look for: the use errors from healthcare professionals (HCPs) or patients, misunderstandings, bugs, and external issues. This article covers what makes these risks critical and how our team keep patient safety top of mind as they address them.

risk Management digital therapeutics

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