Safety Assurance Cases for Medical Devices
This 3 day course provides attendees with an understanding of safety assurance cases and how they can be used to demonstrate the validity of safety claims made for medical devices. It covers the elements of assurance cases, the structure and approach for using them to demonstrate medical device safety, how to create and review a safety assurance case with good arguments and evidence, and common logic fallacies seen in assurance cases.
Objectives
At the conclusion of the course, attendees will be able to:
- Recognize assurance case concepts and principles and why safety assurance cases are used
- Apply different formats for safety assurance cases and the pros and cons of each format
- Determine how safety assurance cases are constructed and the variations in detail and rigor appropriate for different levels of device risk
- Construct a safety assurance case
- Review safety assurance cases and identify common fallacies in arguments
Format
This 3 day program provides intensive coverage of the elements of a safety assurance case. Examples and interactive exercises will allow participants to apply their new knowledge to create and review safety assurance cases for a variety of scenarios.
Program At-A-Glance
DAY ONE |
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DAY TWO |
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DAY THREE |
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Who Should Attend?
This course is targeted to professionals who may be directly involved in creating or reviewing safety assurance cases, such as engineers, risk managers, and regulatory and quality professionals. No previous experience with assurance cases is required. To gain maximum benefit from this course, it is recommended that attendees have a basic understanding of risk management concepts and risk management terminology used in ANSI/AAMI/ISO 14971:2007 - Medical devices - Application of risk management to medical devices.
Dates & Hotels
| DATES | LOCATION | PHONE & RATES |
| September 30 - October 2, 2013 | The Westin Arlington Gateway 801 North Glebe Road Arlington, VA 22203 Website |
703-717-6200 $209 single/double Rate through 9/1/2012 |
| NOTE: Reservation request should be made as soon as possible, but no later than the 'rate through' date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. | ||
Fee and Registration
Fee includes PowerPoint presentations and case studies; relevant standards and/or technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
| REGISTRATION TYPE | FEES |
| AAMI corporate and institutional member | $1835 |
| AAMIindividual member | $1935 |
| Nonmember | $2235 |
| Government employee | $635 |