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QNX Solution for Medical Market Kosuke Abe, APAC Sales Team

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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

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• 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

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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

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Imaging

Requirements • Reliability • Real-time • Scalability • Multicore

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Modalities • Mammography, digital mammography • Computed tomography (CT) • Ultrasound • Magnetic resonance imaging (MRI) • Nuclear– SPECT/PET

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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

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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

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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

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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

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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

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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

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• 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

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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

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© 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