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“As a medical startup, we initially had no knowledge of MDR and the associated regulations. However, the videos, tutorials, and templates from OpenFramework Regulatory were incredibly helpful. They equipped us with the necessary knowledge to implement our processes effectively and successfully achieve the certification (Class IIb). I highly recommend their resources to any startup. Their templates and tutorials are not only informative but also adaptable to specific needs. An excellent resource indeed.”

Juraj Janak
CEO at S-Case
Case Study #1: Shipping a MDD Class I Device In 3 Months
Case Study #2: Helping pregive ship their app, BabyCare, as a Medical Device

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Recent Updates

Unlocking Market Access: Navigating Reimbursement Challenges for Medical Device Startups in Europe

In the dynamic world of healthcare innovation, startups developing medical devices face a myriad of challenges, with reimbursement standing as a pivotal hurdle to overcome. Particularly in Europe, where healthcare systems vary widely across countries, navigating the reimbursement landscape demands a tailored and strategic approach.

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MDR Post-Market Surveillance: The Ultimate Guide

Okay, you managed the ISO 13485 certification, walked through endless discussions with your notified body and finally you can put the CE sticker on your medical device and conquer the world! Congratulations.

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What Is Clinical Evidence (MDR)?

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The True Shadiness Of QMS Software For Medical Devices

If you want to bring a medical device to market, it’s likely you’re also looking for QMS software. And if you have no idea what any of those things are, then here’s a quick primer! As always, I’m grossly oversimplifying everything.

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