Until recently, the Medical Device industry was comprised of a handful of large and well-established hardware manufacturing organizations. As those devices have become more software-driven, so too have software development companies begun working closer with the medical device manufacturers. In addition to supplying software to those manufacturers, these software companies now also independently develop medical products built for consumer devices. Today, the majority of medical device software in the EU is developed by small and medium sized software companies.
The biggest challenge facing fledgling medical device software developers is adhering to the same set of rigorous regulations as the established medical device manufacturers, to ensure that their products are safe to use.
This case study examines the challenges that small-to-medium software companies face when entering the regulated medical device industry, how they can overcome them, and the tools they should use.
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