Medical Development Group Announces June 1-3, 2011 Special Course - "Safety Assurance Cases and Security for Medical Devices"

Waltham, MA, April 21, 2011 --(PR.com)-- The Medical Development Group announces its June 1-3, 2011 course for specialists responsible for high-risk medical devices. A crucial element of the FDA's 510(k) initiative will require that medical device submissions be organized as assurance case reports; moving to this format is intended to help smooth the premarket review process. This course is designed to provide an understanding of what assurance cases contain, how to construct them, and what makes for a stronger assurance case argument. Presenters include Dr. John C. Knight, Univ. of VA and Dependable Computing Inc., Dr. Kimberly S. Wasson, M. Anthony Aiello, Dependable Computing Inc., Dr. Nathanael Paul, University of Tennessee.

Who should attend:

Managers responsible for software controlled medical devices
Regulatory affairs specialists
Engineers designing medical devices with software control and network connectivity
Quality assurance specialists for medical device firms

Course content:

Structure, purpose and use of the assurance case
GSN: the Goal-Structuring Notation
Argument patterns and fallacies
Why an assurance case can help improve review
What the FDA reviewer will look for in an assurance case submission
How to organize design, risk-management, and testing information into assurance case argument form
Scope of vulnerabilities when medical devices are networked
Strategies to ensure security and data privacy of medical device communications
This in-depth course is being offered exclusively through MedDev Group. Registration is limited to 30 students, so register early

Date and Time: June 1, 2, 3: 8:30 AM - 5:30 PM
Location: The Conference Center at Waltham Woods (Massachusetts Medical Society)
Registration Fee includes course materials, buffet lunch, and snacks:
MDG Member $1,295; Nonmember $1495. through May 4th
May 5th and later: Member $1,595; Nonmember $1,795

For full course description and presenters see http://www.meddevgroup.org/courses

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