From Documentation to Regulatory Readiness
This is the final entry in our three-part series on the development of a mitral valve heart implant. So far, we’ve taken you from the earliest design stages through preclinical and human clinical trials. In this final post, we’ll explore how we built a world-class quality system and assembled the technical and regulatory foundation to support our CE marking journey.
Technical Documentation: Built for Scrutiny
Comprehensive technical documentation has been central to our CE marking strategy. Throughout development, we meticulously prepared a design dossier that includes all key components: risk assessments, clinical evaluation materials, validation records, and ongoing testing results.
These files are being developed in full alignment with the EU Medical Device Regulation (MDR) and are structured to support upcoming regulatory assessments. Our commitment to transparency and thorough documentation positions us well for future audits and inspections across global markets.
Global Readiness: FDA Alignment and U.S. Market Preparation
Although our primary regulatory goal for this implant has been CE marking, we’ve proactively aligned our processes with U.S. FDA standards as well. MDS actively participated in pre-Investigational Device Exemption (pre-IDE) meetings, engaged in Q-submissions, and contributed to the IDE application process to prepare the implant for future U.S. trials and market entry.
This dual-track approach ensures our technologies can scale beyond Europe—adapting to a wide range of global regulatory frameworks without sacrificing speed or quality.
Commercial Alignment and Purpose-Driven Innovation
Throughout this journey, we’ve kept our focus on both clinical need and commercial viability. We’ve supported our partners in identifying and refining the intended use of their technologies, helping to define optimal clinical indications and predicate device pathways. By ensuring that device development aligns with real-world practice and regulatory fit, we’ve enabled a smoother path to market for deep-tech innovations.
A Vision Coming to Life
With the final stages of clinical evaluation and regulatory preparation underway, we’re proud to stand behind a transformative solution that reflects the best of medical engineering and clinical collaboration. At MDS, we remain committed to pushing healthcare forward—partnering with organizations that share our vision of improving lives through purposeful innovation.
Let’s shape the future of healthcare together. Reach out to explore how MDS can support your next medical device breakthrough. If you’re interested in hearing more, you can also book a meeting with us to discuss how we could help your product design!
