Remedical GmbH

Problem:
MedTech companies face growing complexity in meeting global regulatory requirements such as ISO 13485, EU MDR, and FDA 21 CFR. Processes like risk management, post-market surveillance, and complaint handling are often manual, fragmented, and error-prone, leading to compliance risks, high costs, and delayed market access. These inefficiencies hinder innovation and patient safety in an industry where precision and reliability are critical.
Solution & Team:
Remedical, founded by Nikolas Neels, offers CURA, a SaaS platform that automates compliance workflows and integrates risk and quality processes across the product lifecycle. With deep MedTech expertise and a scalable solution, we target a global market exceeding $500B, enabling faster, safer innovations.