Watch now as GlobalScot Ray McKinney who has spent three decades working in regulatory compliance for software in life sciences, seeks to guide companies navigating the complexities of dealing with regulators.

Meeting the expectations of the US FDA, and other regulatory bodies around the world, presents a substantial hurdle when introducing any new software product serving the life sciences industries. Whether critical-to-life code like that in a pacemaker, or something as seemingly simple as a training database for pharmaceutical firms, developers are expected to be able to prove they have followed a documented software development lifecycle (SDLC) with risk-appropriate design and test documentation.

A successful software product introduction requires achieving a careful balance between the competing forces of time-to-market, validation cost, and consequences of compliance failure. Determining how-much-is-enough is often the subject of passionate debate.

This talk by GlobalScot Ray McKinney seeks to outline approaches to overcoming the compliance hurdles of the pharmaceutical and medical device industries. The goal is to allow developers to plan with confidence and help demystify a subject often shrouded in myth.

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