CS Medico is a Denmark-based medical device regulatory consulting firm. Its founder, Claus Steen, has more than 15 years of experience in the medical device and IVD industries. Based on the website, its core offering is not SaaS software, but professional compliance consulting for manufacturers of medical devices, in vitro diagnostic products, and drug-device combination products, with a focus on helping companies address EU MDR, IVDR, and MDR Article 117 requirements.
Its services cover three main areas: MDR compliance transition, IVDR transition, and drug-device combination products. On the MDR side, services include gap analysis, GSPR mapping, technical documentation development, clinical evaluation reports, post-market surveillance systems, PSUR, and communication with notified bodies. For IVDR, the firm works on product classification, performance evaluation reports, scientific validity documentation, PMPF, and coordination with EU reference laboratories. Its Article 117 services focus on drug-device combination products such as pre-filled syringes and delivery devices, supporting coordination between the EMA and notified bodies, device–drug interface documentation, and quality system alignment. The website also highlights professional frameworks such as ISO 13485, ISO 14971, and MEDDEV 2.7/1 Rev 4.
The website does not disclose packages, hourly rates, project pricing, or payment methods, and only provides a “Schedule a Free Consultation” entry point. Before procurement, companies would need to further confirm the service scope, pricing model, delivery timeline, responsibility boundaries, and whether a long-term advisory agreement can be signed. For organizations with strict budget management requirements, this is an information gap.
Its strengths are a high degree of vertical focus, a relatively complete founder profile, and an emphasis on services delivered directly by senior regulatory professionals. Judging from the articles on the website, the firm appears to have a solid understanding of Article 117, the differences between MDR and IVDR, and ISO 14971 risk management. The downside is that it is not an enterprise software platform: there is no visible information on user permissions, workflows, APIs, third-party integrations, data security certifications, or cloud/self-hosted deployment. Team size, customer cases, and SLA details are also insufficiently disclosed.
It is best suited for small and medium-sized medical device companies planning to enter the EU market, transitioning from MDD to MDR or from IVDD to IVDR, or developing drug-device combination products. It is especially relevant for teams that need external expertise to strengthen technical documentation and notified body communication. Access from China cannot be determined from the available text, so actual website availability should be tested. Payment methods are also not disclosed. If a company is mainly focused on China NMPA registration, it may still need to work with a local regulatory consultant or consider an eQMS/QMS software alternative.
⚠ This review is compiled from public sources and does not constitute a purchase recommendation. Verify all facts on the vendor's official site. Verify on csmedico.dk official site.
csmedico.dk is an Denmark SaaS Tools provider. TG4G tracks its product information, an overall rating of 6.0/10, and a China-accessibility score of Limited (proxy recommended). Click "Visit Official Site" to reach csmedico.dk directly.