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.