Medical Device – Regulatory and Clinical Guidance, From Concept to Commercialization
Get it right the first time. With the optimal regulatory and clinical strategy, we help you navigate medical device development efficiently — from concept to approval, all from a single source.
Our international, multidisciplinary experts with proven experience in medical device development will lead you through every step.
We provide tailored packages that include an efficient CE-mark (EU)/FDA (USA) strategy, compliance readiness, and clinical investigations — streamlining the entire journey from development to commercialization and ensuring patient benefit as early as possible.
Meet One of Our Team Members
Lauren Willgeroth
Medical Device Manager
Lauren holds a Master of Science in Physics and has more than 10 years of experience with medical devices. She is an expert in all aspects of technical documentation, with a special focus on hardware and software products, and is currently expanding the regulatory toolbox to include AI.
She has worked on active devices, non-active implantables, software, reprocessables, and devices with a measuring function. Lauren understands the requirements from the authorities and will pragmatically guide you through the development of your product. She is based in LINK Medical’s Berlin office in Germany.
