Focusing on Traceability in Software Development for Safe Medical Devices
The IEC 62304 standard was developed to address safety concerns triggered by the rising number of devices in the medical industry that use software. Checking each stage of software development to help create a functionally safe medical device is plain common sense, but the collation of evidence of compliance with the standard itself can be a real headache.
Traceability is key to the success of medical device approval, and yet too often it tends to be a background task. This webinar explains why making traceability the focal point of your development efforts from the beginning of development and throughout the project lifecycle can help ensure that the collation of evidence becomes second nature rather than a secondary overhead.
Join QNX Software Systems and LDRA for this web seminar as we offer insights using examples from our experience with safe systems, not only in the medical devices sector, but also in other fields.
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.
Chris Ault, Product Manager, QNX Software Systems
Chris Ault is a product manager at QNX Software Systems, where he focuses on the medical and general embedded markets.
Prior to joining QNX, Chris worked in various roles, including software engineering, engineering management, product management, and technical sales, at AppZero, Ciena, Liquid Computing, Nortel, and Wind River Systems.