Software FMEA for Medical Devices - By Compliance Global Inc.

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Category FMEA, Failure Mode Effects Analysis, fmea example, fmea template, fmea software, fmea training, Software FMEA fundamentals, ISO 14971, iso 14971 training, risk assessment process, iso quality, FDA reviews, food and drug administration, fda approval process, fda approval, fda cfr, fda food regulations

Deadline: October 22, 2015 | Date: October 22, 2015

Venue/Country: New Hyde Park, U.S.A

Updated: 2015-09-29 14:21:33 (GMT+9)

Call For Papers - CFP

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 mitigation

? Configuration accounting

? Post control risk evaluation

? Example of a good Software FMEA

Learning Objectives:

? Reporting the results of FMEA

? Using FMEA as a living document

? Software change control policies

Who Will Benefit:

? Software Managers

? Software Developers

? Hardware Engineers and Managers

? System Engineers

? Quality Engineers

? Quality Auditors

? Medical Staff evaluating Risk, Safety or Effectiveness

? Quality or Regulatory Staff assigned to complaint

? Marketing Managers

? Device Users

Level:

Beginner

For more information, please visit https://www.complianceglobal.us/product/700233

About Compliance Global Inc:

Compliance Global Inc; is a training (webinar) organization based in New Hyde Park, New York, providing world-class compliance trainings and online webinars by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare, BFSI, Life Science & HR streams for improving the knowledge base of the customers. Our trainings are contemporary, simple and cost-effective with easy access and great delivery experience. Compliance Global is a multifaceted entity, an absolute knowledge repository.

Our varied industry expertise ranges across Life Science (Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance), Healthcare, HR Compliance, BFSI, Food & Dietary Supplements, Insurance, Accounting & Taxation and other Cross Industry streams.

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