A Special Report from “The Silver Sheet” When Is an iPhone a Medical Device?

A Special Report from “The Silver Sheet” When Is an iPhone a Medical Device? A special report from “The Silver Sheet” on increasing FDA regulation of consumer electronics and software used in medical devices and electronic health records.

FREE FOR A LIMITED TIME!

A Special Report from “The Silver Sheet” When Is an iPhone a Medical Device? A special report from “The Silver Sheet” on increasing FDA regulation of consumer electronics and software used in medical devices and electronic health records.

FREE FOR A LIMITED TIME!

Roll up your sleeves, dig into this eye-opening special report and prepare to face the future of healthcare. No one can afford to ignore this 16-page Special Report aimed at device manufacturers, quality control managers, even physicians and hospital administrators.
Prepared by “The Silver Sheet’s” expert analysts, this FREE Special Report (a $129 value) answers all the business-critical questions you may not even have thought of yet:

 

 

What’s wrong with incremental improvements to medical devices that run on software?

Incremental improvement – the standard operating procedure in device development – is rapidly becoming a liability when it comes to medical device software. The continued use of aging microprocessors and platforms is increasingly alarming FDA regulators as medical device design is leaving the hardware of the 1990s behind. Will you make the same mistake others have – a mistake that already has FDA’s attention?

An array of medical devices is susceptible to software problems

Software problems have cropped up in all sorts of devices, including infusion pumps, ventilators and implantable devices, according to the FDA. A "Silver Sheet" analysis found that software problems accounted for 71 of 726 Class II medical device recalls in calendar year 2008.

Verification and validation activities often incorrectly performed by some software firms

When it comes to device software, there are a variety of ways a firm can fall down, including failing to follow design control requirements outlined in the Quality System Regulation. According to QSR Sec. 820.30(g), "Design Controls," design validation "shall include software validation ... where appropriate."  And the preamble to the QSR - FDA's elaboration on the regulation, published along with the QSR in 1996 - provides a bit more detail. "Software must be validated when it is part of the finished device," the preamble states. "FDA believes that this control is always needed, given the unique nature of software.”

How does an iPhone become a medical device?

Many manufacturers don’t even know their product is a medical device eligible for FDA regulation, and that can lead to costly mistakes, redesigns, and even recalls. In this report, you’ll find out precisely how the FDA defines the new software and portable communications devices so popular in hospitals, which standards you must follow in manufacturing, and what mistakes will bring CDRH down on you.

What kind of software testing should we use?

In this report, FDA regulators and QSR experts describe software quality assurance testing that helps device manufacturers stay out of trouble, including both black box testing and white box testing.

Proper documentation also key, and IEC 62304 standard can help

The FDA is also demanding about the documentation that device manufacturers use to communicate what their products do and how they do it. A company's requirements document should include the following: functional and capability requirements; software system inputs and outputs; interfaces between the software system and other systems; software-driven alarms, warnings and operator messages; and much more listed in this report.

When does simple data entry turn into a regulatory problem?

Electronic health record systems will drive the urgent healthcare reforms the nation is calling for. And that creates an unprecedented opportunity for medical device manufacturers. But that opportunity comes with inherent problems for those who want to take advantage of it, and regulators are bearing down. What are these problems, and how can you deal with them effectively?

EHR vendors unhappy about possible FDA oversight regulatory

FDA took a first step toward enforcing regulation of a type of software involved in electronic record-keeping - medical device data systems (MDDS) - with a February 2008 proposed rule.. The move has caused some anxiety in the health IT industry, including among EHR companies. In comments on the proposed rule, the Electronic Health Record Vendors Association argued that EHRs do not meet the definition of an MDDS or any kind of medical device.

This is one of “The Silver Sheet’s” most widely-read Special Reports ever, and if the QSR is even remotely a part of your job, don’t miss the chance to get it FREE.

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