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.

When there are changes to any kind of business regulation, companies must take action to ensure they remain compliant. In a heavily-regulated industry like medtech, changes usually require businesses to produce extensive documentation to revalidate both the product and the quality management system behind it.

It’s no secret that an effective Quality Management System (QMS) is essential for compliance with the EU’s incoming Medical Device Regulation (MDR) as well as ISO 13485 certification.