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Wie Dynamische Softwareanalyse die Zulassung von Medizingeräten vereinfachen kann

February 2014
12 pages
Wie Dynamische Softwareanalyse die Zulassung von Medizingeräten vereinfachen kann

Zwei der großen Herausforderungen für Hersteller von medizintechnischen Geräten sind heute a) Sicherheitsnachweise und b) Zulassungsprozesse. In diesem Whitepaper beleuchten wir, wie dynamische Softwareanalyse helfen kann, nachzuweisen, dass die Sicherheitsanforderungen erfüllt werden und was entsprechende Tools können sollten. Wir bilden außerdem Entwicklungstätigkeiten auf die IEC 62304 Anforderungen ab und zeigen auf, welche Eigenschaften das einzusetzende Embedded-OS mitbringen sollte.


Einleitung -

Nachweis der Verlässlichkeit -

IEC 62304 -

Dynamische Analyse -

Auswahl des Software-Analyse Werkzeuges -

Fazit -

Anhang A: IEC 62304 und Entwicklungstätigkeiten -

Anhang B: Das Embedded-Betriebssystem - [+]

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Mark Pitchford

Mark Pitchford

Mark Pitchford has over 25 years’ experience in software development for engineering applications. He has worked on many significant industrial and commercial projects in development and management, both in the UK and internationally including extended periods in Canada and Australia. Since 2001, he has specialised in software test, and works throughout Europe and beyond as a Field Applications Engineer with LDRA Ltd.

Mark studied at Nottingham Trent University and has been a Chartered Engineer for over 20 years. He has published numerous articles on software validation, the use of SOUP (software of unknown pedigree) in safe systems, and standards such as ISO 26262.

Chris Ault

Chris Ault

Chris Ault is the senior product manager responsible for QNX Software Systems’ medical software portfolio, including an Operating System compliant with the IEC 62304 standard. Recognized for his software expertise, Chris has written articles for Electronic Design, Embedded Intel Solutions, and Design & Elektronik and presented at events such as the Medical Devices Summit, mHealth, Embedded World, and the Embedded Systems Conference.

Before joining QNX, Chris was a senior product manager focused on virtualization technologies. He has held positions of increasing responsibility with hardware and software vendors, including Ciena, Nortel, Catena Networks, and Liquid Computing.

Chris holds degrees in computer science, electronics, and economics from Algonquin College and Carleton University.

See Also...

Using Static and Runtime Analysis to Improve Developer Productivity and Product Quality

Fault Tree Analysis with Bayesian Belief Networks for Safety-Critical Software

Protecting Applications Against Heisenbugs

Memory Errors in Embedded Systems

Using an IEC 61508-Certified RTOS Kernel for Safety-Critical Systems

Building Functional Safety into Complex Software Systems, Part I

Building Functional Safety into Complex Software Systems, Part II

Clear SOUP and COTS Software for Medical Device Development

Which OS for IEC 62304 Medical Systems?

Ten Truths about Building Safe Embedded Software Systems

Other whitepaper topics: Recent, Automotive, German Whitepapers, HMI + Graphics, Industrial, Medical, Multimedia + Acoustics, Networking, Operating Systems, Security + Defense, Safe Systems, Tools