Webinar · Palm Beach, Florida
Software FMEA for Medical Devices - By Compliance Global Inc.
Education, Training
Key numbers
- Editions on record
- 1first in 2015
About Software FMEA for Medical Devices - By Compliance Global Inc.
Overview: The Failure Mode Effects Analysis breaks down the analysis of complex software functions into manageable subsystems and modules. It can have a number of variations which address different aspects of the device. The variants can be User Level FMEA template, Subsystem FMEA, Interface FMEA, Module Level FMEA, and Code Level FMEA. Marketing should lead the effort on User Level FMEA. The aim is to thoroughly review what can go wrong in use and what kind of misuses may be made. The device manufacturer must consider how to protect patients in case of misuse of the devices Many patients have died from the inadvertent misuses. It is also important to include the analysis of software trustworthiness, safety, reliability, and maintainability. These have many risks associated with them that could adversely affect the performance of the device. Why Should You Attend: The ISO 14971 training and its risk analysis tool FMEA has been recognized by FDA, and in Europe, for risk mitigation of medical devices. Compliance with ISO 14971 will therefore be crucial not in meeting regulatory requirements but also as a most important part of design control. The Food and Drug Administration reviews the results of the FMEA as preview to device recalls, during adverse event analysis, and complaint investigations. FMEA may be very difficult and tedious for the case of complex systems which have multiple functions consisting of a millions of lines of code. This difficulty can be increased by the number of possible operating modes, as well as by including consideration of software change control policies. Therefore a thorough understanding by the entire staff is critical in efficient FMEAs. Areas Covered in this Webinar: • Software FMEA fundamentals • Frequent mistakes in FMEA • Different levels for FMEA • System Functions FMEA • Subsystem level FMEA • Module level FMEA • Code level FMEA • Interface FMEA • Severity rating scale • Probability rating scale • Risk assessment • Risk mitigatio
From our listing of this edition. Details may have changed since.
Editions
| Year | Dates | Where | Exhibitors | Visitors |
|---|---|---|---|---|
| 2015 | 22 Oct 2015 | Webinar Venue Online | — | — |
Past editions from the bvents archive (2008–2019) and organiser figures where they were published.
Questions
When is Software FMEA for Medical Devices - By Compliance Global Inc.?
The next dates haven't been confirmed. The last edition we have on record was 22 Oct 2015.
Where is it held?
The last edition we have was at Webinar Venue, Palm Beach, Florida.