2-day In-person Seminar on "Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management 2014

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.

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.

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