Optimizing the Development of Certified Medical Devices

Overview:
Electronic devices—now commonplace in the medical industry—spark concerns over the safety and security of device software and the liability risks should something go wrong. The IEC 62304 standard was developed to address these safety concerns, checking each stage of software development to help create a functionally safe medical device.

Safety is best addressed at the beginning of development and tools play a pivotal role in ensuring you can meet your product’s development and certification needs. This webinar offers insights from QNX Software Systems and LDRA on how to optimize the development path to successfully achieve medical device certification. We will draw on experiences not only in the medical devices sector, but also in achieving successful compliance with similar standards in other fields.

Using practical examples, we will share key best practices and details on:

• Making use of IEC 62304 development templates
• Designing good development practices across the development lifecycle
• Specifying requirements to ensure requirements traceability through all phases of development
• Gaining IEC 62304 compliance using LDRA qualifiable and QNX certified products
• Illustrating best how-to practices for safe design using key aspects of the QNX Safety Manual
• An overview of the QNX® Neutrino® RTOS Safety Assurance Case
• The concept of leveraging "Proven in Use" data
• The importance of safe design training courses and pre-audit consulting
• Scheduling code inspections (starting inspections early eliminate errors!)
• Securing the Code—70% of security vulnerabilities rise from programming errors

Attendees will learn powerful and practical methods for achieving IEC 62304 while getting to market, minimizing risk and optimizing productivity—all critical factors in good medical design.

Presenters:
Mark Pitchford, Field Applications Engineer, LDRA
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. For the past 10 years, he has specialised in software test and works throughout Europe and beyond as a Field Applications Engineer with LDRA.

Bob Monkman, Director of Business Development, Embedded Markets, QNX
Bob Monkman is the Director of Business Development for Embedded Markets at QNX Software Systems Limited with a specific focus on the Medical and Safety/Security segments. With 25 years of computing industry experience, he specializes in embedded operating systems for high reliability environments, systems management middleware and high availability. Before joining QNX, Bob held a variety of positions in product marketing and management, product strategy, branding, strategic alliances, and business development with Enea, Penguin Computing, MontaVista Software, Wind River Systems, and Microtec Research. Bob also held applications engineering, professional services and hardware/software development roles at Ready Systems and Tellabs. Bob has a BSEE degree from the University of Illinois.