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If your device qualifies as a medical device, certification is mandatory in every market where it’s sold. As part of our onboarding process, we’ll help you determine if your device requires certification—at no cost. Then you can begin your certification journey with Medflow.
We understand budget concerns, but consider the long-term savings. Traditional consultants can cost tens to hundreds of thousands of euros. Our platform significantly reduces costs by streamlining the entire certification process, saving you from costly delays and missteps. You get a comprehensive, affordable solution that covers everything you need in one package—an investment that pays off by getting you to market faster.
That’s exactly why Medflow was created. We’ve simplified the complex certification process into manageable steps, guiding you through each phase with clear instructions, predefined activities, and deliverables. You don’t need to be an expert—we provide the expertise to keep you on the right track, whether you’re a startup or an established company.
While consultants are valuable, they often come with high hourly rates and may not offer a complete solution. Medflow provides an end-to-end platform that gives you control over the entire certification process, offering greater cost efficiency. Our platform is built on extensive real-world experience, delivering a powerful tool that goes beyond traditional consulting—at a fraction of the cost.
We strongly recommend that certification preparation occurs alongside product development. Treating certification seriously from the start ensures that your product can reach the market without unnecessary delays. Aligning certification efforts with development makes the process smoother and more efficient.
You might try, but consider the productivity lost as your team navigates complex legal documentation. Alternatively, hiring expensive consultants adds to costs. Outsourcing this critical task to affordable experts like us is a minimal investment that saves time and resources.
Regardless of who’s leading your certification process, they’ll use software or lots of paper to manage documentation. Traditional software is often outdated and cumbersome. With Medflow, you benefit from high-quality content and modern, intelligent features that make the process more efficient and user-friendly.
Our CEO, Morten, has guided numerous devices through certification, backed by over 20 successful regulatory approvals. Whether you’re a startup or an experienced company, our platform is designed to meet your needs. Trust in a solution supported by real-world experience and a deep understanding of the regulatory journey—you’re in expert hands.
While certification can take up to a year even under ideal conditions, our step-by-step platform helps you estimate and manage the workload more precisely. This accelerates your time to market and reduces effort over time.