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.
The goal is to develop and implement risk balance throughout the design, coding, installation and device use process. It includes FDA guidance on Incorporating human factors into risk and FDA guidance on premarketing risk assessment. The important areas include assessing resources requires, a good policy, good methods for assessing the effectiveness including the effectiveness of the management policy, qualifications of personnel.
Why should you attend?
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.
For the medical device industry, there are numerous standards now in play that guide the product development cycle. The internationally recognized IEC 62304 standard prescribes the software development processes, activities, and tasks for effective medical device software development. IEC 62304 specifically calls out that the manufacturer shall apply a risk management process complying with ISO 14971. Both the FDA and IEC 62304 specify the use of ISO 14971. Under IEC 62304, the manufacturer must specify a safety classification to each software system according to the possible effects on the patient, operator, or others resulting from a hazard to which the software system can contribute.
Areas Covered in the:
Overview of ISO 14971
Overview of IEC 63204
The best tools for risk analysis
Application of tools such as PHA,FMEA,FTA
Identifying missing requirements in specifications
Intelligent problem fixing before they happen
Paradigms for efficiency and efficacy of risk control
World class best practices in risk analysis
Accounting for risks from unintended use and misuse
Case histories
Who Will Benefit:
All Senior Managers
Software Engineers and Managers
All Hardware Engineers and Managers
Software team Leaders
R&D Staff
Software Testers
Quality Assurance Staff
Regulatory Staff
Marketing Staff
Servicing Staff
Product Safety Staff
Agenda:
Day One:
FDA requirements for software risk analysis
What constitutes software under FDA requirements
Software risk management through good design practices
Principles of efficient risk analysis
Overview of ISO 14971 for software
Role of probability in software development
FDA guidance for software risk assessment for pre-market approval
Good practices for requirements analysis
Negative requirements analysis
Workshop on negative requirements analysis
Six hat thinking for efficient risk analysis
Software risk prediction using Preliminary Hazard Analysis
Assigning the criticality based on the probability of the harm and severity for each hazard
Mitigating risks using world class practices
Workshop on PHA
Risk Analysis using Software Functions FMEA
Workshop on Software FMEA
Module level FMEA
Code level FMEA
Day Two:
Workshop on code level FMEA
Risk Analysis Using the Fault Tree Analysis
Constructing fault trees
Workshop on Fault Tree Analysis
Design improvements through Fault Tree Analysis
Device alarms requirements to avoid user risks
Risk analysis for interoperability performance
Risk management through good design control
Risk assessment for human factors
Risk control of unexpected use and misuse
Risk control through software verification
Risk control through software validation
Risk control for software maintenance
Developing safety assurance cases
Controlling off-the-shelf software risks
Selecting software structure for safety
Selecting software architecture for safety
Maintaining effectiveness of controls during risk analysis, risk evaluation and risk Control
Defensive programming
Management responsibility
FDA documentation requirements
Summary
Speaker:
Dev Raheja
Author - Safer Hospital Care (Taylor & Francis), Patient System Safety
Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for variety of industries. His clients include Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont. He has served as Adjunct Professor at the University of Maryland for five years for its PhD program in Reliability Engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement, former chair of the Reliability Division, and member of the Biomedical Division. He is a Senior Member of IEEE.
Location: Chicago, IL Date: August 20th & 21st, 2015 Time: 9:00 AM to 6:00 PM
Venue: Courtyard Chicago O'Hare
Venue Address: 2950 S. River Road Des Plaines Illinois 60018 USA
Price: $1,295.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until July 10, Early Bird Price: $1,295.00
From July 11 to August 18, Regular Price: $1,495.00
Contact Information:
NetZealous LLC,
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http://www.globalcompliancepanel.com
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