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!