Medical Device Software

Tested. Validated. Documented.

When a piece of software influences patient health, special care must be taken in its creation to make sure that a patient is not put at risk by a fault or bug. No one wants a faulty software program to incorrectly influence healthcare decisions.

This type of software is often classified as a medical device which requires it to be manufactured to a specific set of standards to control the quality of the results.

One of the ongoing topics that is routinely debated in the medical community is what types of software are considered medical devices. For example, in the United States electronic medical records systems used by physicians and hospitals to record patient data is not currently classified as a medical device. In Canada this type of software was recently included in the list of medical devices and vendors have been given a 2 year period to certify their products manufacturing process.

A lot of software is now aiding in decisions that directly affect patient care. Although there isn’t a definitive classification in all situations, more and more companies are erring on the side of caution and building their software to medical device standards even when it is not mandated.

If you are considering developing software that is on the fringe of what is currently considered a medical device, you may want to consider developing the software as if it were currently a medical device. The boundaries that encompass what is a medical device continue to expand and it is considerably more work to backtrack than follow the process up front.

Developing medical device software is done by following strict manufacturing standards that ensure the quality of the software. These standards are defined by various regulatory bodies throughout the world. In the United States, the standards are controlled by the FDA and HIPAA. In Canada and Europe, the ISO and IEC commissions set the standards. SageKey is qualified to develop medical grade software that meets these standards.

Additionally, device manufacturers in the United States who intend to release a medical device to the market are required by Section 510(k) of the Food, Drug and Cosmetic Act to inform the FDA at least 90 days prior to release. This Premarket Notification (PMN or 510K) allows the FDA to determine whether or not the device is substantially equivalent to a current medical device. Although as a custom software provider, SageKey is not considered the manufacturer of the device, we do have experience in providing documentation to support 510K filings.

Example of Our Work

DIALYSIS DATA MANAGER

Electronic Medical Records system to manage data from kidney dialysis machines.

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Amgen Pharmaceutical hired SageKey to develop a full Electronic Medical Records system to manage patient data within Dialysis Clinics. This software system contains all of the patient records and replaces the traditional patient chart. As dialysis patients need to come in to the clinic 3 times a week for a 4 hour appointment, paper records often grow to a file many feet thick.

The software we developed collects data directly from the dialysis machine and downloads patient laboratory results electronically. A rich set of graphing and reporting tools were added for physicians to view their patients' health over time. The software was developed to FDA medical device standards and passed an independant audit for the applicable FDA standards for patient privacy, medical devices and electronic signatures.

Notable Features

• C#
• VB6
• SQL Server
• HL7
• Medical Device Interface
• HIPAA
• 21CFR Part 11