Published inmerantix·Nov 13, 2019Certifying a Medical Device as a Startup, Part 2: V-Model Doesn’t Mean Waterfall Development (IEC 62304)How does your startup develop software? You’re probably thinking: Hm, our developers sit behind computer screens and write code. Simple, right? Yes, unless you’re developing software which is a medical device. …Regulatory10 min readRegulatory10 min read
Published inmerantix·Oct 24, 2019Certifying a Medical Device as a Startup, Part 1: How not to Fail in the First MonthLet’s do an experiment. I want you to learn how to develop software. I won’t teach you, though. I’ll only give you access to a desk, a chair and a laptop which is connected to the internet. And then I’ll give you three months time. Will you succeed? Given that…Medical Devices9 min readMedical Devices9 min read