Compliance with the Medical Device Regulation (MDR) doesn’t end with a Notified Body’s stamp of approval and certification for the EU market. In fact, that’s just the beginning of the compliance journey for medical device companies.

Regulations are there for a reason. In the medical device sector, they keep patients and medical professionals safe from harm. However, under the weight of regulatory burden, companies need external experts to help put together their technical dossier, and ensure it meets the requirements of the Medical Device Regulation (MDR).

The Medical Device Regulation (MDR) introduces stricter requirements for launching healthcare software on the EU market. As with any new regulation, it can take time for companies to get compliance right. It’s also inevitable that mistakes will be made, resulting in long delays and increased development costs – without specialist guidance.