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Compliance In Focus


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Posted by Tracey Tytko on Tue, May 24, 2016

The World of Digital Health

We are in an era where mobile platforms, such as smartphones, tablets and wearable devices have become a necessity. Mobile applications that run on these platforms provide a variety of entertainment options (games, videos, etc.), allows you to check your electronic mail, and interact with family and friends. Other applications that are being developed are now allowing us to track our health and wellness, and even communicate with healthcare providers, remotely. These types of applications are known as either mobile health applications (mHealth) or mobile medical applications (MMAs).

Topics: Mobile Medical Applications, FDA, Digital Health,

Posted by Natalie Jarmusik on Wed, Mar 04, 2015

Home Health Care: The Impact on Medical Device Design

For a patient receiving a medical device or for the doctor who is administering the device, more often than naught, the primary concerns of either party include: “Is this device going to be effective?” and “Is this device safe?” However, what individuals may not consider when asking these types of questions is the extent to which the device designer has already taken into account such concerns. For every medical device that has its own clinical trial or has made it to post-market, there is a team of engineers and designers who make it their job to consider the structural components and environmental factors that will allow the device to remain safe, yet effective. Often times the environment that these medical devices call home is the hospital where the patient was admitted. But as home health care becomes more predominant in today’s society, designers now have a new set of challenges to consider when constructing medical device prototypes.

Topics: Mobile Medical Applications, Home Health Care, Medical Device Design

Posted by Michael Marotta on Mon, Nov 06, 2017

Keeping Track of Your Health 24/7

On August 5th we introduced the notion that there is an overwhelming abundance of information available at the fingertips of the consumer.  In Part One we took a closer look at the role of the FDA in Personalized Genomics and direct-to-consumer genetic tests. Now in Part Two we will take a closer look at the role of the FDA in regulating mobile medical applications.

Topics: Personalized Medicine, 24/7, Mobile Medical Applications, FDA

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