Time: June 22, 2017 at 9am to June 23, 2017 at 6pm
Location: Boston, MA
Street: Embassy Suites Boston Logan Airport
City/Town: Boston, MA
Website or Map: http://www.globalcompliancepa…
Event Type: risk, management, in, medical, devices, industry
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Apr 21
Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software.
To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.
Who Will Benefit:
The course will introduce the main elements of risk management with emphasis on software issues and the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.
Venue: Embassy Suites Boston Logan Airport
Address: Embassy Suites Boston Logan Airport 207 Porter Street Boston, MA 02128
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until May 10, Early Bird Price: $1,295.00 From May 11 to June 20, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00
$6,475.00 You Save: $2,590.00 (40%)*
NetZealous DBA as GlobalCompliancePanel
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