A guide to practical Risk Management - Applying ISO14971 and IEC62304

Event Details

Time: October 3, 2019 at 9am to October 4, 2019 at 6pm
Location: Philadelphia, PA
Street: WILL BE ANNOUNCED SOON
City/Town: Philadelphia
Website or Map: http://www.globalcompliancepa…
Phone: 8004479407
Event Type: seminar
Organized By: John Robinson
Latest Activity: May 14, 2019

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Event Description

Description:

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.

Speaker:

Markus Weber

Principal Consultant, System Safety Inc.

Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.

Location: Philadelphia, PA Date: October 3^rd and 4^th, 2019 and Time 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON

Price:

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 August 20, Early Bird Price: $2,000. From August 21 to October 01, Regular Price: $2,200.

Use this promo code GCP50 to get 50% off.

Sponsorship Program benefits for seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

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