Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959
 info@antrix.com

Mobile Medical Applications

1. Product Description

Mobile Medical Application (Mobile Medical App)

Mobile Platforms are defined as commercial off-the-shelf (COTS) computing platforms, with or without wireless connectivity, that are handheld in nature. Examples of these mobile platforms include mobile computers such as the iPhone®, BlackBerry® phones, Android® phones, tablet computers, or other computers that are typically used as smart phones or personal digital assistants (PDAs).  

Mobile Application or "mobile app" is defined as a software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server.  

Mobile Medical Application is a mobile app that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and either: is used as an accessory to a regulated medical device; or transforms a mobile platform into a regulated medical device

The intended use of a mobile app determines whether it meets the definition of a "device." As stated in 21 CFR 801 intended use may be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives. When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.

Example – LED included on a mobile platform with a mobile app to make that LED light.
Blood Glucose Monitoring Device etc.

Regulatory Agency Approval

Properly validated solutions are more likely to avoid regulatory scrutiny in the form of regulatory observations, citations or violations. These time consuming and disruptive events can pose a real business risk as it relates to agency approval of new product introductions and sales of existing products.

Antrix ensures that your mobile medical app software is compliant to elements of regulations pertaining to your industry. For medical device we ensure that you are compliant to ISO 13485 standards, FDA regulations and IEC 62304 Medical Device Software Life Cycle Process. We will help you in doing complete software life cycle process implemeation, software risk and software safety analysis and creationg of 510(K) and Technical File.

Antrix will help you in

Defining your

  • Mobile Platform

  • Mobile Application (Mobile App)

  • Mobile Medical Application (Mobile Medical App)

  • Regulated Medical Device

  • Mobile Medical App Manufacturer

Scope – FDA intentions for regulatory requirements

Regulatory Approach For Mobile Medical Apps

Mobile Medical Apps For Which FDA Will Apply Regulatory Oversight

FDA and ISO Regulatory Requirements

Requirements For Mobile Medical Device Manufacturers Subject To Regulatory Oversight

Expectations For Mobile Medical App Distributors

Software Risk Analysis and Software Safety Analysis

Modbile Medical Device Software Lifecycle implementation

Mobile Medical App Labeling

Mobile Medical App 510(k) Creation and Submission

Mobile Medical App Technical File Creation

Antrix will ensure that you adhere to FDA Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263280.htm


2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our customized product based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 90 % > 70 % > 60 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our product. Company size is based on annual sales as per FDA classification.


3. Price

$ sales@antrix.com or call