IEC62304 (International standard for medical device software)
Software Verification and Validation
Critical Software Issues
Software Hazard Mitigation Strategies
Software Item, Unit and System Definition
Software Tools and Development Environment
Real-Time System Challenges
Software Requirements and Design Specification
Software Failures as Hazard Sources
Mitigation Traceability and Effectiveness
Software Unit and Integration Testing
IEC60601-1:2005 (Technical standards for the safety and effectiveness of medical electrical equipment)
Section 4 Risk Related Issues
References to Risk Management
Special PEMS Issues
The IEC TRF (technical report form)
Compliance for Non-Software Related Issues
PEMS and IEC62304
ISO 14971 (Requirements for a risk management system for medical devices)
Verification Strategies
Post Mitigation Risk
Architectures, Redundancy and Diversity
Hazard Mitigation Traceability
Residual Risk
Failure Mode and Effect Analysis / FTA
Alarm Systems as Mitigations
Usability as Hazard Source and Mitigation
Risk Management Life Cycle
Safety Integrity Levels
Initial (unmitigated) Risk Assessment
Hazard Latency Issues
Mitigation Strategies and Priorities
System Validation / Mitigation Validation
Safety Requirements
Mitigation Architectures
Risk Rating Methods
Hazard Identification
Risk Management Planning
Hazard Domains
Verification Planning
Risk Control Bundles
Who should Attend
Project Managers
Quality Assurance Managers
Software Engineers
Regulatory / Compliance Managers and Specialists
Hardware Engineers
System Engineering
Past Events
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2019 - 03-04 Oct 2019, Philadelphia, Pennsylvania, United States (85310)
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2019 - 2019, (73496)
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2018 - 27-28 Mar 2018, Hilton Zurich Airport, Switzerland (73495)
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2018 - 29-30 Jan 2018, DoubleTree by Hilton Philadelphia Airport, Pennsylvania, United States (72459)
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2017 - 22-23 May 2017, Mandarin Orchard Singapore (64283)
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2017 - 18-19 May 2017, Hilton Zurich Airport, Switzerland (65856)
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2017 - 09-10 Mar 2017, Four Points By Sheraton San Diego Downtown, California, United States (64787)
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2016 - 10-11 Nov 2016, Four Points by Sheraton Chicago O'Hare, Illinois, United States (39384)
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2013 - 01-02 Aug 2013, DoubleTree by Hilton Hotel San Diego Downtown, California, United States (39383)
Important
Please, check "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" official website for possible changes, before making any traveling arrangements