When Is an iPhone a Medical Device?

 

FDC-Windhover announces the publication of a new special issue of "The Silver Sheet" on the increasing FDA regulation of consumer electronics and software used in medical devices and electronic health records systems.

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 report asks, and answers, 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?
• How does an iPhone become a medical device?
• When does simple data entry turn into a regulatory problem?
• Could a simple software repair wind up costing a life?

And how do we put all of the pieces of software, hardware and technology together to guarantee privacy, connectivity, effectiveness, safety … and profitability?

Device software
Read this report to find out how incremental improvement – the standard operating procedure in device development – is rapidly becoming a liability when it comes to software. Will you make the same mistake others have – a mistake that already has FDA’s attention?

Cell phone or device?
Many manufacturers don’t even know their product is a regulation-eligible medical device, 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.

EHR systems
Electronic health record systems will drive the urgent healthcare reforms the nation is calling for. And that creates an unprecedented opportunity for 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?

These are just some of the issues and actionable guidance included in this report. And it could only be delivered by “The Silver Sheet,” the most widely-read resource for in-depth analysis of quality control and compliance issues for the device and diagnostic industries.

To purchase this special issue of “The Silver Sheet,” please click here.

To find out more about this special issue or what “The Silver Sheet” can do for you, please contact Sean Smith at [email protected] or 240-221-4535.