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Medical Device Software Risk Management Standard | Software Expert 2018

Medical Device Software Risk Management

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Who should attend?

Software has introduced (or been blamed for) some serious safety hazards All medical device standards intersect on the topic of risk management Risk analysis starts with the intended use statement Risk information is available from multipl sources - use them! Note that safety is an emergent property Changes are often the biggest sources of risk Don't ignore the human factors side; understanding your users is crucial to safety Applying engineering risk methods to software requires us to translate some concepts Though standards draw a roadmap for risk management, WE must figure out the route Risks often arise when we add new features - so incremental risk management is the most effective Forget the notion that "software can't hurt anyone" Never conduct risk analysis by using a checklist from 14971 Exploding technology brings numerous chances for risk to multiply

Details

Course "Medical Device Software: An Incremental Approach to Risk and Quality Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien.

Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world.

Regulatory bodies are placing increased emphasis on risk management, and technology shifts are introducing new sources of risk. Newer Lean-Agile methods are recognized by the FDA as a good way to accomplish risk management.

Techniques for risk management are well established, but require specific interpretation when applied to software. In this session, we will show a way of knitting risk management into the development process, so that it is integral to product development, not a ten ton caboose dragging the train back down the mountain.

 

 Location: San Diego, CA Date:  January 18th & 19th, 2018 and Time: 9:00 AM to 6:00 PM

VenueDoubleTree by Hilton San Diego Downtown   1646 Front St, San Diego, CA 92101, USA

 

 Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Register now and save $200. (Early Bird)

Until December 10, Early Bird Price: $1,295.00 From December 11 to January 16, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees   Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901345SEMINAR?pharmiweb-January-2018-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

Prices

Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)

Contact

Event Manager
john.robinson@globalcompliancepanel.com

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