CE Marking Support: MedEnvoy Partnership

At MedEnvoy, we take pride in helping innovative companies bring their medical devices to market with confidence, with CE marking support being one of the key ways we make that possible. In this video, Ray Schumin, Director of Quality and Regulatory Affairs at Medical Predictive Science Corporation (MPSC), shares his experience working with our team as they pursued CE marking for their neonatal monitoring product, Hero.

Ray highlights the importance of credibility in the European market, even for a small company, and how MedEnvoy’s support helped MPSC navigate complex regulatory requirements without unnecessary hassle. He emphasizes the value of having a trusted partner who not only understands compliance but also provides ongoing reminders, guidance, and a personal connection when questions arise.

For MPSC, MedEnvoy’s expertise meant more than just regulatory checkboxes, it provided peace of mind, smoother processes, and confidence that quality systems were in place. Most importantly, Ray underscores how critical it is for startups and small companies to invest in regulatory and quality support early, ensuring a solid foundation for long-term success.

Watch the full video above to hear Ray’s story in his own words:

How MedEnvoy Can Support 

Ray’s story underscores the importance of having the right partner when navigating complex EU regulatory requirements, especially for CE marking support. For small companies like MPSC, CE marking is more than a compliance checkbox, it’s essential for credibility, market access, and long-term growth. With MedEnvoy’s guidance, they were able to simplify the process, gain peace of mind, and focus on their mission of supporting neonatal care.

Looking for support with CE Marking, EU Authorized Representative (EU AR) service, or EUDAMED registration? MedEnvoy provides end-to-end regulatory solutions to help medical device and IVD manufacturers achieve compliance and expand globally.

Talk to an Expert to learn how we can support your regulatory journey.