2-day In-person Seminar on “Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management” in Berlin, Germany

Summary of the Workshop:

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.

Learning Objectives:

Introduction into Risk Management and Quality System Integration

Risk Management to ISO 14971:2012

Usability and Risk Management

Software Risk Management (IEC62304 / FDA software reviewers' guidance)

Software Risk Management (IEC62304 / FDA software reviewers' guidance)

Safety / Assurance case

Meet your Expert:

Markus Weber is owner and Principal Consultant with System Safety, Inc. He 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 his consulting company, he was a software safety engineer for the German approval agency, TUV. 

RAC Credits: 12

Date: October 23^rd & 24^th, 2014 

Event Details: http://bit.ly/PracticalRiskManagement

Location: Berlin, Germany

Venue: Hilton Hotel Berlin, Mohrenstra 30 10117 Berlin Germany

Venue Link: http://www3.hilton.com/en/hotels/berlin/hilton-berlin-BERHITW/index.html 

Registration: Open Enrollment

Delivery: Face-to-Face event

Price: $1595.00

Until September 15, Early Bird Price: $1,595.00

From September 16 to October 21, Regular Price: $1,795.00

Course Web Site: https://www.globalcompliancepanel.com/control/~product_id=900117SEMINAR/practical-risk-management_Germany

Organizer:
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management.

Provider:

GlobalCompliancePanel

                John Robinson

                161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

                Phone: 800-447-9407

                Fax: 302-288-6884

                Email: support@globalcompliancepanel.com

                Website: www.globalcompliancepanel.com