Talent
Description
Design Control, Verification and Validation for Software in
Medical Device
Location: Webinar
Speaker: Dev Raheja, MS,CSP Dev Raheja, MS,CSP, author of the book Preventing Medical Device Recalls, 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. Course Description:
Majority of the recent FDA recalls are software related. Perhaps most striking is the fact that one-third faced multiple recalls. It is a reminder that recalls can happen to any company—especially as more and more companies turn to complex technologies. While most standards are helpful, they can be considered only minimum requirements where self interest prevails. Even in healthcare where compliance to standards is at highest level, many patients die from devices errors in software designs, usually blamed on user errors. Understanding how mishaps can happen before they happen and preventing them by design is the key. Verification and validation helps in achieving the ultra-high software reliability. Course Objectives:
The FDA reviews the results of the performance tests during pre-market approvals, and in complaint investigations. Therefore a thorough understanding of designing device for reliable and safe performance is critical for efficient business strategy. Outline:
· Regulatory requirements on software risk management · Paradigms for efficiency and cost reduction · Identifying unknown risks · Design control is the key to good software requirements · Developing design control plan · Principles of software verification · Developing verification plan · Principles of software validation · Developing validation plan
MANAGEMT REPORTS
Target Audience:
To Enroll for This Program today please click hear
Thank you & Regards, Sean Sharpe
Senior Associate – Operations & Customer Services
Toll Free: +1 866-978-0800
Direct: +1 602-910-4676
Fax: +1 888-883-7697
|
Presented By
1:00pm to 2:30pm
General Admission: $199.00
21+
10 +1 866-978-0800 PAST EVENTS
Thursday, March 5th
Complianz World Past Event
Tuesday, March 3rd
complianzworld Past Event
|