Upload
others
View
38
Download
0
Embed Size (px)
Citation preview
© QNX Software Systems Limited
QNX Solution for Medical Market Kosuke Abe, APAC Sales Team
© QNX Software Systems Limited
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
2
© 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
Trends impacting device manufacturers
© QNX Software Systems Limited
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
4
© QNX Software Systems Limited
Imaging
Requirements • Reliability • Real-time • Scalability • Multicore
5
Modalities • Mammography, digital mammography • Computed tomography (CT) • Ultrasound • Magnetic resonance imaging (MRI) • Nuclear– SPECT/PET
© QNX Software Systems Limited
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
6
© QNX Software Systems Limited
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
7
© QNX Software Systems Limited
8
The QNX solution for medical devices includes:
• IEC 62304 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
© QNX Software Systems Limited
9 IEC 62304 Statement of Compliance
• IEC 62304 formally recognized by the FDA:
Recognition Number 13-8: IEC 62304 Ed. 1.0, medical device software software life cycle processes
• Derived from IEC 61508
• Includes independent third-party assessment
© QNX Software Systems Limited
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
© QNX Software Systems Limited
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
© 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
Trends impacting device manufacturers
© QNX Software Systems Limited
What makes QNX different?
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
13
© QNX Software Systems Limited
© 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 [email protected]