Applying ISO 14971 and IEC 62304 to medical device software

158245439.jpg

Risk management of software used in medical devices has to be implemented diligently, completely and correctly, scrutinizing the gaps thoroughly and correcting them right from the very start of product development. This is critical because of the following reasons:

  1. Medical products that have gaps or are implemented incorrectly or incompletely suffer serious ailments such as impediments or delays in production. Further, such products fail to get the required certification and/or approval;
  2. Given the close linkage between most activities and the development lifecycle; almost no activity can be isolated and performed with retrospective effect after detection of a gap. As a result, all the activities performed till the identification of gaps become unproductive and redundant. When this happens, the company has to start from the beginning, irrespective of the stage at which an anomaly gets detected, incurring huge delays and cost overruns.

The solution to these problems is to embed software risk management into the bigger scope of overall risk management. This is the only real solution to problems associated with faulty product development. Globally applicable standard requirements such as ISO14971 and IEC62304 are major guidelines that help medical device companies get the risk management of software used in medical devices right. These standards have made risk management central to and a mandatory component of almost any activity in the medical device industry.

Getting it right from start till finish

Regulatory requirements set out in ISO14971 and IEC62304 standards that deal with risk management of software used in medical devices need to be implemented in the right manner, if medical device companies have to clear regulatory hurdles and meet quality standards. Expert professional trainings that help them do this will give them an understanding of how to design, implement and test critical medical device software in a regulatory compliant environment.

All these will be part of a learning session that is being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the regulatory compliance areas. This two-day, live seminar will have Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, as the course Director.

To gain the benefit of expert training from the Director of this seminar; please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900750?wordpress_SEO  to register.

Globally applicable standard requirements

Markus will explain the requirements set out by international consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, which has led to risk management being a mandatory component of almost any activity in the medical device industry.

Since the need to embed software risk management into the bigger scope of overall risk management is a critical aspect; Markus will introduce all the steps needed for designing, implementing and testing core medical device software in a regulatory compliant environment, even as they adhere to the principles of risk management. Another important learning Markus will impart is system level risk management and the resulting interfaces to software.

The safety case method

A well-established method for collecting and consolidating all safety related information together in one location, so that all risk related activities are comprehensively summarized, and the safe properties of a device demonstrated, is what is called the ‘Safety Case’ or ‘Assurance Case’ document.

Although as of now, the FDA requires this method for only infusion pump submissions; this system of documentation is almost certain to become standard practice in the future across all devices that come up for approval. At this course, Markus Weber will introduce the basic concepts and content of safety assurance cases. He will also explain and illustrate their utility for internal and external review of safety related information.

Tips for practical application of risk management principles

Real-life examples and proven tips and tricks that make the application of risk management practical and beneficial will be offered at this webinar. The Director will describe the system level issues of risk management as well as the increasingly important software related issues of critical systems.

He will introduce the concept of an assurance case to make the combined effort needed to design, implement and verify a safe device transparent. An important outcome of this learning is that it will help participants to meet and comply with regulatory requirements with highly lessened overheads and resource burdens.

Risk Management Seminar for Applying ISO14971 and IEC62304

 

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.

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.

Location: Zurich, Switzerland Date: May 18th & 19th, 2017 and Time: 9:00 AM to 6:00 PM

 

Venue: Hilton Zurich Airport

Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,695.00 (Seminar Fee for One Delegate)

Until April 10, Early Bird Price: $1,695.00 from April 11 to May 16, Regular Price: $1,895.00

Register for 5 attendees   Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)*

 

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com

 

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900892SEMINAR?channel=mailer&camp=seminar&AdGroup=wordpress_May_2017_SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel