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»MD Review
Upcoming Seminars
The New Landscape of Usability and Human Factors Issues for all Medical Devices
Date/Time: TBA
Current International Thought on Software Development - A Life Cycle Approach
Date/Time: TBA
A Review of Enterprise Risk Management and ISO 31000 for Pharmaceutical and Medical Device Companies
Date/Time: TBA
Featured Speaker
Your Hosts
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Future Planned Seminars:
The New Landscape of Usability and Human Factors Issues for all Medical Devices
Date/Time: TBA
Current International Thought on Software Development - A Life Cycle Approach
Date/Time: TBA
A Review of Enterprise Risk Management and ISO 31000 for Pharmaceutical and Medical Device Companies
Date/Time: TBA
Previous Seminars:
New Requirements for IT - Networking Medical Devices in Hospitals and Medical Facilities, featuring Sherman Eagles
Thursday, August 7, 2008, 1:30pm EST
There is increasing scrutiny of networked medical devices in the clinical environment by the FDA and other regulators. The FDA has received reports of patient injuries when medical devices are incorporated into hospital networks. Hospitals and other medical providers are looking for solutions to control the risks associated with these networks. The International Electrotechnical Commission (IEC) is developing an International Standard to define the process and requirements for these activities (IEC 80001).
Sherman Eagles, an expert in the field of medical device software, is the co-convener of the group developing IEC 80001 and will be the guest speaker for this audio learning seminar. Professor Alf Dolan, an expert in the field of Risk Management and convener of ISO/IEC 14971 will also be a speaker with Mr. Eagles. Stan Mastrangelo of Virginia Tech will be the program moderator.
This one hour program will:
• Discuss the rationale for development of the Standard
• Describe the requirements in the current committee draft
• Provide insight into managing the risk associated with implementing an IT network.
• Discuss the role of the Technology Risk Manager and other roles when incorporating a medical device into a network
• Describe a process model for networking Medical Devices
• Do's and Don'ts for manufacturers and hospitals
• Question and Answer Session
Medical Device Review audio conferences are the ideal way to get fast, concise, and up- to-the-minute information on this and other important topics. You can join the call from your office or mobile phone, or share the call with your team. Register now!
New Risk
Management Requirements for CE Mark of Electrical Medical
Equipment, featuring
Paul Fabry
Thursday, March 20th, 2008, 1:30pm EST
Attention Medical Device R&D, Quality Assurance, and Regulatory Affairs Managers – do you need to meet the requirements of IEC 60601 to CE mark your Medical Device in the near future? Are you aware that the IEC 60601 standard has moved to the third edition, which contains significant additional requirements related to the Risk Management process and documentation required for device design and manufacturing?
On March 20th, listen in to the Medical Device Review audio conference to get the latest information on the IEC 60601 standard. Industry expert
Paul Fabry will fully discuss the new developments in IEC 60601, developments that affect all device manufacturers who market electrical medical equipment. Your hosts,
Stan Mastrangelo and Alf Dolan, will moderate the discussion, and field questions during the Question & Answer portion of the conference. This interactive 75-minute discussion will give you the latest information available from people who have been deeply involved in the process of developing the new standard. The conference will also enable you to ask your questions via the web, and have them answered during the presentation.
Topics include:
• A summary of risk management-related changes to the third edition
• The impact these changes will have on manufacturers
• Different approaches by Notified Bodies to assessment
• Predicted timetable
• Question and Answer Session
MMedical Device Review audio conferences are the ideal way to get fast, concise, and up- to-the-minute information on this and other important topics. You can join the call from your office or mobile phone, or share the call with your team. Register now!
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MD Review Audio
Learning Seminars are Sponsored by
Virginia Tech's
Center for Applied Health Sciences.
www.cahs.vt.edu
The Center for Applied Health Sciences is dedicated to the
advancement of risk management through graduate education,
seminars and workshops, and targeted learning opportunities
for corporations, regulatory agencies, and professional
groups in the food and healthcare industries.
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