Medical Device Summit's Software Risk Management and Validation Workshop 

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 Considerations for Medical Device Product Development 

November 13-14, 2012 Loews Hotel, Philadelphia, PA             

Hotel Room Reservations Link: http://www.loewshotels.com/en/Philadelphia-Hotel/GroupPages/EMP111412

Medical devices that include software raise special challenges at every step, from product conceptualization through design, development and testing, to regulatory approval and postmarket oversight and support.

Communication between hardware engineers, RA/QA, and IT professionals may be less than ideal.  Software developers speak a language of their own – they may not be aware of device design and regulatory constraints, while those whose experience is rooted in hardware may miss new issues that software introduces.

How do you establish an effectively functioning team to determine what functions should be software-controlled, to evaluate risk, validate custom or off-the-shelf software, or manage bugs and updates?

This interactive workshop will help regulatory, quality, and R&D professionals understand the special issues of software and share best practices on communicating with internal and external IT experts throughout the product life cycle in order to maintain effective control over product design and performance, and reliably meet user needs and expectations.

Presented by School@TheSummit, the Educational Arm of Medical Device Summit

Workshop Management:

• Thomas Maeder, Conference Director, Medical Device Summit
  
• Donna-Bea Tillman – Senior Consultant, Biologics Consulting Group, former Director, Office of Device Evaluation, FDA – Conference Chair Person

Speakers to be announced soon!

Who should attend:

• RA/QA professionals
• R&D managers
• Design engineers
• Product stewards
• Executives with management responsibility

What you will learn:

• Medical device software regulations and standards
• Development strategies for devices with software
• Determining functions that should be software controlled
• Custom versus off-the-shelf software solutions
• Risk management and software
• Human factors considerations and user interface design
• Software localization – designing for a global environment
• Software validation
• Fixing bugs, updates, and adding new features

Presented as a Hybrid event.  Attend on site (best option) or from your desktop (next best option to being there)

Attendance Options:  "On site" is the traditional way of participating in conferences.  You travel to the event and participate in the discussions and interact with your peers, colleagues and speakers in person.  This is the best option!

"Virtual" attendance is similar to participating in a webinar.  You will see and hear the presentations through your computer.  You can ask questions to the speakers through the chat Q&A function.  This option is best for those who can not travel to the event OR the timing of the event is in conflict with their schedule.

Both "On site" and "virtual" attendees receive an archived recording of the conference about 6 weeks after the event.

If your schedule is in conflict with the event but you would like to attend it, then we advise to select the "Virtual" attendee option which allows you to purchase the recording so that you can watch it On Demand at a later date.

Register Now and Save! Early Bird Discount expires Friday, October 19. Register Now! Limited seating.

 

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Registration FAQs:

How much does it cost to attend?   $1,395 before October 19 and $1,695 after.

Team Discounted Registration:  We offer a reduced registration rate for each additional person you register.  Under Teammate Information, click on "Add".  For each additional person you register, the fee is $995 before October 19 and $1,395 after.

What materials will be provided?  On-Site attendees will receive printed copies of the presentations at the event.  Off-Site attendees will receive pdf copies of the presentations emailed to them before the event.  Both On-Site and Off-Site Attendees will receive an archived recording of the conference.

Will I earn any Continuing Education Units (CEUs)?  Yes.  You will earn 1.15 CEUs and will receive a Certificate of Attendance.

How do I Pay?  When you click on the "Register Now!" link below, you have several options to pay for your registration, company check, credit card and PayPal. 

Company Check: On the Registration form (link below), select Check and follow the directions.  Payment must be received prior to the event.  Email us if you need an invoice generated for the registration.  If your organization requires it, Innovative Publishing Co. LLC is a women-owned US corporation.  Email us if you need Innovative Publishing Co. LLC's tax ID. or a W-9 emailed to you.

Credit Card or PayPal: Select the PayPal button.  You do not have to have a PayPal account.  The PayPal option allows you to use the following credit cards: American Express, Visa, MasterCard, Discover.  "IPC LLC" is the merchant name that will appear on your credit card statement.

Does the registration fee include my hotel room?  No, you are responsible for your own travel and hotel expenses.  There is a discount on the hotel rooms for a limited time.

When should I arrive?  We strongly encourage you to check into the hotel the night before the event.

Does the registration fee include meals?  Yes, breakfast, lunch and breaks.  There will be a cocktail networking reception at the end of the first day.

What happens if I register but find that I can not attend the event?  Substitutions are encouraged.  If you can not find a colleague to take your place and need to cancel your registration, you must email your cancelation notice to rbiros@InnovativePublishing.net.  Refunds will be issued less a 20% processing fee.  If you cancel your registration seven business days prior to the event or if you are a "no-show" to the event,  there is no refund for your registration fee.

Can I ask questions to the speakers?  Yes!  It is encouraged for both On-Site and Off-Site Attendees!  You are with your colleagues and peers and should feel confortable asking questions.  If you would like to have specific questions addressed by the speakers, please email those question to Tom Maeder, Conference Director at tmaeder@InnovativePublishing.net two weeks prior to the event.

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