The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: March 19, 2019 at 9am to March 20, 2019 at 6pm
Location: DoubleTree by Hilton Philadelphia Airport
Street: 4509 Island Avenue, Philadelphia, PA 19153
City/Town: Philadelphia, PA
Website or Map: https://www.globalcompliancep…
Event Type: seminar, on, iso, 14971, risk, management, training-iec, 62304
Organized By: John Robinson
Latest Activity: Feb 14, 2019
Course "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" has been pre-approved by RAPS as eligible 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: Philadelphia, PA Date: March 19th and 20th, 2019 and Time 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153
1 ATTENDEE $2,000, Regular Price: $2000, Register for 1 attendee
5 ATTENDEES $10,000, Regular Price: $10,000, Register for 5 attendees
10 ATTENDEES $20,000, Regular Price: $20,000, Register for 10 attendees
Until February 20, Early Bird Price: $2,000. From February 21 to March 17, Regular Price: $2,200.
Use this promo code GCP50 to get 50% off.
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