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DESIGNING MEDICAL DEVICES FOR HIGH RELIABILITY AND SAFETY: 2-day LVC
Presented By Complianzworld
Tuesday, November 18th at 9:00am EST - Wednesday, November 19th, 2014
Online sale ends: 11/17/14 at 6:00pm EST
Complianzworld
USA, NY 10036
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Talent

Complianzworld

Description

Live Virtual Class - LVC Details

When?         November 18th and 19th, 2014

Where?        Your Home or Office

Time?

Your Expert Presenter

Dev Raheja, MS, CSP, author of the text Preventing Medical Device Recalls, is an international Risk Management and Quality Assurance consultant for Healthcare, Medical Device, and the Aerospace Industry for over 25 years.  He applies evidence base safety techniques from a variety of industries to Healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He has conducted training in several countries including Sweden, Australia, Japan, Germany, UK, Singapore, Taiwan, South Africa, Finland, and Brazil.

 

Prior to becoming a consultant in 1982 he worked at GE healthcare as Supervisor of Quality Assurance and Manager of Manufacturing, and at Booz-Allen & Hamilton as Risk Management consultant for nuclear and mass transportation industry. He has served as Adjunct Professor at the University of Maryland for five years for its PhD program in Reliability Engineering. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management, is Associate Editor- Healthcare Safety for the Journal of System Safety, and teaches webinars on medical device safety and reliability.

 Those Who Should Attend this LVC

  • Engineers and Managers
  • Regulatory Affairs Professionals
  • Marketing Managers
  • Service Managers
  • Project Managers and Engineers
  • Vice Presidents of Engineering and Software Development
  • Quality Assurance Staff
  • IT Professionals looking to make the design process efficient

 

Three Easy Ways to Register

Course Description

DESIGNING MEDICAL DEVICES FOR HIGH RELIABILITY AND SAFETY

 

According to FDA data, typically between 13 to 75 medical devices are recalled every day (majority of these recalls are either Class II or Class III recalls).  This poses a huge danger to patients from medical devices in large numbers. These dangers are present in many devices such as: MRI equipment, CT scanners, nuclear medicine equipment, defibrillators, infusion pumps, ventilators patient monitoring systems, electronic health record computers. There are also dangers in medical accessories such as: interface connectors, surgical trays, syringes and valves, IV tubes that transport blood, catheters. While medical devices are obviously designed to benefit patients, they can also cause harm. In 2013, the US Food and Drug Administration (FDA) recalled more than 1200 medical devices—the highest number ever recalled in a single year. Since 2004, 86% of all recalls have been Class II recalls, while 7% have been Class III and 6% have been Class I. One in three FDA device recalls was due to a software error. This 2-day workshop will provide attendees with best practices for designing medical devices that are highly reliable, ultra-safe, at lower life cycle costs. Several case studies will be covered from the presenter’s experience of over 30 years with companies such as GE Healthcare, Siemens Medical Systems, and Johnson & Johnson.

 

[CLICK HERE FOR AGENDA]
Day Wise Agenda:

Day 1

8:00 – 8:30 AM: Registration

                                              
8:30 – 10:00AM:
WHAT ARE THE DANGERS IN MEDICAL DEVICES ACCORDING TO HOSPITALS

·         Inherent technologies

·         Equipment software

·         User interface

·         Device reliability

·         Defective components

·         Sneak conditions

·         Expired sterility

·         Accessories

·         Incorrect labelling information or instructions

·         Incorrect servicing

·         Unprotected patients

10:00 – 10:15AM: Break

 

10:15 – 12:00 noon: UNDERSTANDING THE SCIENCE OF HIGH RELIABILITY

 

·         Conduct Requirements Analysis to Identify Missing Requirements

·         Specification for Durability, and Reliability

·         Specification for User Interface and Usability

·         Specification for Maintainability

·         Specification for Prognostics

·         Specification for Safe Software

·         Negative requirements Analysis for Worst Case Scenarios

·         Conducting Preliminary Hazard Analysis (PHA) to Assess Risks

 

12:00 – 12:45PM: Lunch

 

12:45 – 2:15PM: UNDERSTANDING THE SCIENCE OF SAFETY

 

·         Developing Risk Acceptance Criteria

·         Risk Analysis Using the Preliminary Hazard Analysis

·         Assessing the Risk

·         Mitigating risks using world class practices

·         Risk Evaluation

·         Managing residual risks

 

 

2:15 – 2:30AM: Break

 

2:30 – 4:00PM: PREVENTING FAILURES AND MISHAPS DURING EARLY DESIGN

·         Functional FMEA on Design Concept to Prevent Failures

·         Conducting Component Level FMEA to Identify Parameters Critical to Quality

·         Conduct Fault Tree Analysis (FTA) to Develop Robust Solutions for Complex Problems

·         The Strategy for Developing Solutions

 

Day 2  

8:30 – 10:00AM:
THE PROCESS FOR  DESIGNING FOR RELIABILITY

 

·         Designing for Durability

·         Designing for Reliability

·         Designing for Inherent Quality

·         Designing to Forgive User Errors

·         Designing for hazard-free maintenance

·         Designing for Packaging

·         Reliability Testing

 

10:00 – 10:15AM: Break

 

10:15 – 12:00 noon: THE PROCESS FOR  DESIGNING FOR SAFETY

·         Designing for Inherent Safety

·         Fault Tree Analysis to Avoid Dangerous Sequences

·         Preventing False Positives and False Negatives

·         Designing for Alerts when the Device is not Performing Accurately

·         Designing to Alert when a Device is near the Low end of the Prognostic Distance

·         Shutting down the device in a safe state if the failure cannot be avoided

 

12:00 – 12:45PM: Lunch

 

12:45 – 2:15PM: DESIGN CONTROL

  • Verification of design inputs and design outputs
  • Process for Engineering Change Control
  • FDA Requirements for Documentation
  • Validation of Design Outputs on Production Units
  • Validation of Design Outputs in Post Marketing Surveys

2:15 – 2:30AM: Break

 

 

 

 

 

 

2:30 – 3:30PM: RELIABILITY AND SAFETY TESTING

  • Quantifying Reliability
  • Fault Seeding Testing For Safety
  • Analyzing Results Using Weibull Analysis
  • Fixing Newly Discovered Risks
  • Summary of the Design Processes

 

 


Presented By

9:00am to 6:00pm
Doors open at 9:00am

General Admission: $799.00

Age
21+

Complianzworld<br> USA, 10036

+1-866-978-0800

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