Let’s face it, many company leaders view quality and compliance as a necessary evil with no obvious business value. But for medical device companies, investment in getting MDR-certified has significant benefits for both risk management and sales. The challenge is getting the management team onboard.

When you combine stringent regulations with a shortage of Notified Bodies and more than 17,000 expiring MDD certifications, it’s easy to see why there’s a growing bottleneck in certifications under the new Medical Device Regulation (MDR).

Software as a medical device is nothing new. However, the way in which companies get software certified under the new Medical Device Regulation (MDR) can be complicated to get right. That’s why it pays to have an experienced expert on hand to steer you through the documentation required by a Notified Body.