Date: | January 29, 2018 - 9:00am - January 30, 2018 - 6:00pm |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | PA, 19153, United States, Philadelphia, PA |
Website for Event: | http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901453SE... |
Topic: | Health Education |
Description: | 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. Overview: 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. Who will benefit: The course will introduce the main elements of risk management with emphasis on 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. Agenda: Day 1 Schedule Lecture 1: Day 2 Schedule Lecture 1: Speaker 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: January 29th & 30th, 2018 and Time: 9:00 AM to 6:00 PM Price: Price: $1,295.00 (Seminar Fee for One Delegate) Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar Contact us today! NetZealous LLC DBA GlobalCompliancePanel Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=... Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/ |
Contact Name: | Event Manager |
Contact Email: | john.robinson@globalcompliancepanel.com |
Contact Phone: | 800-447-9407 |