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Applying ISO14971 and IEC62304 - A guide to practical Risk Management (ntz)

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Applying ISO14971 and IEC62304 - A guide to practical Risk Management

About this Event

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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.

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.

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 combines 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.

Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Project managers
  • Design engineers
  • Software engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Medical affairs
  • Legal Professionals

AGENDA

Day 1 Schedule

Lecture 1:

Introduction into Risk Management and Quality System Integration

Why risk management?

Historical perspective

International regulatory / statutory requirements

Risk Management Lifecycle and stakeholders

Over-reaching concept

Integration into ISO13485

Lifecycle steps

Risk Management Benefits

Liability issues

Streamlining product development

Improving product safety and quality

How to Implement Risk Management into ISO13485

SOP framework

Planning and execution

Monitoring and control

Lecture 2:

Risk Management to ISO 14971:2012

Risk Management Planning

Risk Management Life Cycle

Hazard Identification

Hazard Domains

Hazard Latency Issues

Risk Rating Methods

Initial (unmitigated) Risk Assessment

Mitigation Strategies and Priorities

Mitigation Architectures

Alarm Systems as Mitigations

Risk Control Bundles

Post Mitigation Risk

Residual Risk

Safety Integrity Levels

European special requirements (Z-Annexes)

Safety Requirements

Hazard Mitigation Traceability

Verification Planning

Architectures, Redundancy and Diversity

Failure Mode and Effect Analysis

Tips and Tricks

Q&A

Day 2 Schedule

Lecture 1:

Usability and Risk Management

Use errors as hazard source

User intervention as hazard mitigation

Usability engineering lifecycle

Application specification

Usability Specification

Frequently used functions / primary operating functions

Usability verification / validation

Upcoming changes IEC62366:2014

Lecture 2:

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

Critical Software Issues

Software Hazard Mitigation Strategies

Software Item, Unit and System Definition

Software Failures as Hazard Sources

Software Requirements and Design Specification

Software Tools and Development Environment

Lecture 3:

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

Software Unit and Integration Testing

Real-Time System Challenges

Software Verification and Validation

Mitigation Traceability and Effectiveness

Software Maintenance and Configuration Control

Software Risk Management Process integration into ISO14971

Legacy Software issues

FDA documentation requirements

Upcoming changes in IEC62304:2014

Tips and Tricks

Lecture 4:

Safety / Assurance case

Safety classes

Basic Safety / Environment

Essential performance

Documentation of Basic Safety

Electrical Safety

Mechanical Safety

EMC / RFI safety

Safety margins

Documentation of essential performance

What is essential performance?

Device architectures and mitigation allocation

Device specific mitigations

Software mitigations

External safety

User intervention and alarms

Organizational measures

Levels of protection concept

Verification of safety properties

Type testing

Sample testing

Software verification testing

Inspections

Analyses

Assurance case vs. Risk Management Report

General safety and hazard avoidance

Device / application specific issues

Tips and Tricks

Q&A

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.

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Philadelphia, PA 19102

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