6-Hour Virtual Seminar on Applying ISO14971 and IEC62304 - A guide to practical Risk Management Recorded Webinar | Markus Weber | From: Oct 27, 2020 - To: Dec 31, 2020 |
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 to 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.
Agenda:-
Lecture 1 - Introduction to Risk Management and Quality System Integration
Lecture 2 - Risk Management to ISO 14971:2012
Lecture 3 - Usability and Risk Management
Lecture 4 - Software Risk Management (IEC62304 / FDA software reviewers' guidance):
Lecture 5 - Software Risk Management (IEC62304 / FDA software reviewers' guidance):
Lecture 6 - Safety / Assurance case
Why you should attend:-
The course will introduce the main elements of risk management with an 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 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.
The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combined effort to design, implement, and verify a safe device transparent the concept of an assurance case will be introduced.
The course is mainly based on international consensus requirements such as ISO14971, IEC62366, and IEC62304. It will cover European (MDD), US (FDA), and international risk management requirements from a regulatory and practitioner's perspective.
Who Will Benefit?
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.
