Mobile medical app serve both patients and physicians in dealing with various health conditions. Be it for monitoring chronic diseases or for informing about care decisions, the marketplace for medical apps is encountering a steep rise in demand. Also, the developers are introducing innovative technologies in the apps to help increase healthcare efficiency. According to the reports of the U.S. Food and Drug Administration (FDA) about 1.7 billion smartphone and tablet users are using medical apps in 2018. Surveys also suggest that majority of the users are of the opinion that medical apps improve the quality of life, and this implies that the usage will increase in future. However, with increasing usage, the security concerns are also rising as it is crucial to maintain the privacy and safety of health information. Let’s take a look at the best practices that should be kept in mind while developing mobile medical apps.
FDA audit could be nerve-racking for medical device manufacturers if they are not well prepared. Over the last few years, medical device firms have encountered a significantly heightened number of inspections that resulted in increase in the number of citations. Although difficult, FDA audit is an important aspect of medical device industry. However, especially for startups, the first audit could be quite difficult to handle as the checklist of FDA could scare away the potential investors or customers, hindering the organization’s goal and efforts. Moreover, FDA sometimes announces their audit beforehand but the regulators may also turn up any time for inspection, without any notice. This implies, being a medical device manufacturer, you always need to be prepared for going through an FDA audit.