QNX Solution for Medical Market Kosuke Abe, APAC Sales Team. QNX Software Systems Limited

Transcription

1 QNX Solution for Medical Market Kosuke Abe, APAC Sales Team QNX Software Systems Limited

2 2 QNX medical value proposition Field-proven experience in Class I and II devices Safe, secure microkernel architecture Reliability, scalability with system traceability Hard real-time performance for life-critical devices Certification support and services Connectivity solutions for wired and wireless designs

3 Trends impacting device manufacturers QNX Software Systems Limited Increasing device complexity Enhanced scrutiny from regulatory bodies Move towards more intuitive user interfaces Device connectivity and management Patient data integrity and security

4 4 Diagnostic/therapeutic Requirements Safety Reliability Scalability Secure communication Real-time performance Intuitive HMI Connectivity Device examples ODM hemodynamic monitor Anesthesia monitor Clinical diagnostic equipment Patient monitor Infusion pump

5 5 Imaging Requirements Reliability Real-time Scalability Multicore Modalities Mammography, digital mammography Computed tomography (CT) Ultrasound Magnetic resonance imaging (MRI) Nuclear SPECT/PET

6 6 Consumer/home portable Requirements Reliability Fast response time Low power operation Faster time-to-market Reduced Bill of Materials Device examples Blood glucose monitors Digital pulse/heart rate monitors Pulse oximeter

7 7 Medical device technology requirements Reliability, safety Device scalability Multicore technology Data security & integrity Connectivity (wired, wireless, device) Graphics, user interface Certification, verification and validation support Support longevity Hardware support

8 The QNX solution for medical devices includes: 8 IEC Statement of Compliance Proven in Use data On-site audit (regulatory body participation possible) Safe design training courses Subject matter expert consultancy time (hours) Assisting preparation of safety assurance case Safety system design based on QNX Neutrino RTOS

9 IEC Statement of Compliance 9 IEC formally recognized by the FDA: Recognition Number 13-8: IEC Ed. 1.0, medical device software software life cycle processes Derived from IEC Includes independent third-party assessment

10 Proven-in-Use Data Independently audited field usage data Includes duty cycle assumptions Derived from extensive analysis of deployed QNX products Available for: QNX Neutrino RTOS v6 releases QNX-supported hardware platforms Vertical markets

11 Onsite Audit (regulatory agency participation possible) 2-day audit Regulatory body may participate Tailored agenda to suit device manufacturer needs Review entire quality management system / software development process / product life-cycle model with QNX subject matter experts Review assurance case claims and evidence Question & answer sessions

12 Trends impacting device manufacturers QNX Software Systems Limited Building Reliable and Available Systems Duration: 2 days Designed to help familiarize customers with the knowledge, programming techniques, and tools needed to support safety critical application development

13 What makes QNX different? 13 Building blocks for a complete solution Safe, secure, POSIX-certified OS Provenance for certification Microkernel architecture, adaptive partitioning, and critical process monitoring provide a high level of reliability and scalability QNX Momentics Tool Suite provides visualization tools (memory analysis, code coverage, etc.) for system traceability Off-the-shelf connectivity, graphics, and middleware options

14 2012 QNX Software Systems Limited. QNX, NEUTRINO, MOMENTICS, AVIAGE, PHOTON, PHOTON MICROGUI are trademarks of QNX Software Systems Limited, which are registered trademarks and/or used in certain jurisdictions. All other trademarks belong to their respective owners. The information herein is for informational purposes only and represents the current view of QNX Software Systems Limited (QSS) as of the date of this presentation. Because QSS must respond to changing market conditions, it should not be interpreted to be a commitment on the part of QSS, and QSS cannot guarantee the accuracy of any information provided after the date of this presentation. QSS MAKES NO WARRANTIES, REPRESENTATIONS OR CONDITIONS EXPRESS, IMPLIED OR STATUTORY, AS TO THE INFORMATION IN THIS PRESENTATION. Kosuke Abe, APAC Sales Team kabe@qnx.com