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.
For
more information on Elsevier Business Intelligence products and conferences,
visit us at www.elsevierbi.com,
or send an email to custcare@elsevier.com.
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