Sterling Medical Devices & RBC Medical Innovations are combining to create Vantage MedTech! Meet RBC
Contact Us
Close Form

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

  • This field is for validation purposes and should be left unchanged.

Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
F: 201-301-9169
info@sterlingmedicaldevices.com

Guidelines to Follow When Creating A Medical Device Mobile Application

Author: Dan Sterling | Date: October 7, 2013

Guidelines to Follow
Many new medical mobile applications are being developed for use on mobile platforms (smart phones, tablets, etc.). Before delving into the steps to be taken to develop a medical device mobile application, we should first consider what it takes to consider the application a medical device. According to the FDA Guidance, Mobile Medical Applications have special FDA considerations including:

  • The mobile application can run on a mobile platform or, it can be a web-based application tailored to a mobile device but is executed on a server.
  • The mobile application meets the FDA definition of “device” and either:
    • is used as an accessory to an already-approved medical device
    • transforms a mobile device (smartphone, etc) into an actual medical device

The FDA Guidance document for Mobile Medical Applications can be found here (FDA.gov)

Other Special FDA Considerations Include:

Software Validation: A mobile application that controls the intended use, function, modes, or energy source of a connected medical device, or that creates alarms, recommendations or new information by analyzing or interpreting data from that connected medical device is considered an accessory to the connected device and is required to comply with the controls applicable to that connected device.

Cyber Security: Security is a concern in the use of RF wireless technology because of the possibility of unauthorized eavesdropping on patient data or access to hospital networks. FDA recommends that electromagnetic compatibility (EMC) considerations be an integral part of the design and testing of RF wireless medical devices in compliance with voluntary consensus standards such as IEC 60601-1-2:2001.

Off-The-Shelf (OTS) Software: OTS software is subject to the same security considerations as RF wireless technology. Device manufacturers who use OTS software in a medical device bear the responsibility for the continued safe and effective performance of that device, including the performance of OTS software that is part of the device itself.

Premarket Approval Application (PMA): According to an article in Emergency Medicine News, Class 1 devices do not need premarket review, although they must comply with general manufacturing and registration requirements. High-risk Class II devices, however, will require a PMA.

Special ISO Considerations Include:

ISO 62304: FDA has recognized ISO 62304 as a software development standard. The Article “Developing Medical Device Software to here (FDA.gov) gives a nice overview.

ISO 14971: ISO 14971specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate and control the associated risks and to monitor the effectiveness of the controls. Its requirements are applicable to all stages of the life-cycle of a medical device.

Share this!

Contact Us

  • This field is for validation purposes and should be left unchanged.

Resources

Letters GLP, representing Good Laboratory Practice

February 14, 2022

Preparing for GLP Guideline Regulations in Medical Device Development

Preparing for GLP Guideline Regulations in Medical Device Development As you begin the process of designing, developing, and manufacturing your medical device, there are many things you must...
Read More >
View More Blogs
5 Mistakes Medical Device Startups Make

February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Read More >
View More Videos

July 12, 2022

Scalp Cooling System

Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis