2-day In-person Seminar on Software Risk Analysis Tools for Medical Devices and Risk Mitigation at San Diego

Event Details

Time: October 8, 2015 at 9am to October 9, 2015 at 6pm
Location: DoubleTree by Hilton Hotel San Diego Downtown
Street: 1646 Front Street, San Diego, California, 92101, USA
City/Town: San Diego
Website or Map: http://www.globalcompliancepa…
Phone: 18004479407
Event Type: seminar
Organized By: John Robinson
Latest Activity: Sep 2, 2015

Export to Outlook or iCal (.ics)

0 members like this

Event Description

Overview:

The FDA recalls related to software performance are on the increase for at least five years at the time of this writing. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situations which transform a hazard into harm. We must identify hazards and identify what event can turn them into harm and write software specifications to prevent such combinations. The risk management tools such as FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) can help to mitigate software risks. These tools are covered in the Chapter 4. The mitigations from using the tools become the new requirements in the software specification

Why companies are prone to having past problems in new devices? One of the main reasons seems to be the "weak cognition." It is usually the result of short term memory, inattention to details, insufficient vigilance, or multitasking. This unsafe work propagates unknowingly because of not engaged or disengaged employees, insufficient understanding of customer needs, splitting design among several designers, and ineffective risk analysis. Another big reason is that ineffective device management procedures often touted as 'best practices', are like a bad virus with long incubation period and no early warning, resulting into sudden catastrophic malfunction of the device. Most companies still hold individuals responsible for mistakes instead of fixing the management process.

You have to do risk analysis using the tools in ISO 14971. It is one of the first things FDA will ask for! It is required by law (21 CFR Section 820) and appears on regulatory submission checklists. In addition, it will help define validation that should be done to prove the safety of your actual device use. You can also eliminate costs associated with recalls and lawsuits.