Time: May 22, 2017 at 9am to May 23, 2017 at 6pm
Location: Mandarin Orchard Singapore
Street: 333 Orchard Road, Singapore 238867
Website or Map: http://www.globalcompliancepa…
Event Type: seminar
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Feb 2
for up to 12 credits towards a participant's RAC recertification upon full completion.
Gaps, incorrect or incomplete implementation of safety functionality 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 devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.
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.
Location: Singapore Date: May 22nd & 23rd, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Mandarin Orchard Singapore
Address: 333 Orchard Road, Singapore
Register now and save $200. (Early Bird)
Price: $1,695.00 (Seminar Fee for One Delegate)
Until April 10, Early Bird Price: $1,695.00 from April 11 to May 20, Regular Price: $1,895.00
Register for 5 attendees Price: $5085.00
$8,475.00 You Save: $3390.00 (40%)*
NetZealous DBA as GlobalCompliancePanel
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