Risk Based Approach for Medical Device Design Control

Duration: 60 Minutes
This course will explain how to manage a Design Control program that will meet FDA requirements and minimize chances of your medical device being recalled. Such a program will also help to get projects completed on time and within budget. The important and confusing question of when, in a development process, Design Control begins will be answered. The difference between pre-release and post release change control will be explained.
Medical Device Design Control
Instructor: Edwin Waldbusser
Product ID: 501511
Objectives of the Presentation
  • Reasons for Design Control
  • When Design Control begins
  • Elements of a Design Control program
  • How risk managements fits into Design Control (required by FDA)
  • How human factors fits into Design Control (required by FDA)
  • Change control
  • Understanding validation consists of more than testing
  • Design History File
Why Should you Attend
Attend this webinar to understand Design History File is and get a content checklist. The speaker will also explain the interrelationship between ongoing risk analysis and the design process.

Areas Covered
  • Design Control start criteria
  • Design Inputs
  • Design Outputs
  • Change Control
  • Human factors factored into the design process
  • Risk Analysis factored into the design process
  • Design Validation
Who can Benefit
  • Medical device development engineers
  • Quality Assurance engineers
  • Manufacturing engineers
  • Regulatory personnel
  • R&D personnel and management
  • Process and Quality Engineers
  • QA management
  • Consultants
  • Quality system auditors
$375
Recorded Session for one participant
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  $500.00 Training CD
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  $600.00 Training USB Flash Drive
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Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
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