Launching our MDR Start-up Support Program

Based on input from our customers, we developed this and we are proudly introducing the MDR Start-up Support program: designed for innovative medical start-ups ready to bring their solutions smoothly and with confidence on the market.

Bringing a medical device to the market is exciting, but navigating the MDR can feel overwhelming. That’s where Kiwa Assurance steps in. We give innovative start-ups and SMEs the confidence and clarity they need to achieve CE marking effectively, so you can focus on what matters most: growing your business and delivering life-changing solutions.

What you’ll get:

• Kick-off Intake & Pre-Application. We’ll map out your current status, challenges, and goals -setting you up for a stress-free application process.
• Ready-to-Use Folder Structure & Checklists. No more guesswork. You’ll receive a practical folder system and clear checklists to organize technical documentation and your Quality Management System.
• Structured Dialogue & Roadmap. Stay ahead of requirements, avoid costly delays, and get answers to your questions early in the process.

Why choose Kiwa Assurance?

Because every start‑up deserves a trusted guide to cut through regulatory complexity and accelerate market entry. With us, you’ll gain clarity, ensure compliance, and move forward with confidence.