5 Apr 2017 - by Kaapo Annala

Medical Devices CE

Medical certification is a complicated landscape. In order to get an understanding of a process and find out what should be done, one encounters a significant amount of literature to process. Thankfully, there are people and services that can simplify this puzzle significantly. If you don’t want to read every page of every EU directive, their guidelines, hard-to-decipher pages of Finnish law, and make tens of phone calls just to understand how the actual process works, I can recommend some without hesitation. For Neuro Event Labs, medical device certification is very important. We want to make sure that patient security and their data privacy meets the highest possible standards. That is where the medical certification process helps. To verify that everything possible has been taken into account, and that all possible risks and their mitigation has been recognized and thought beforehand, we abide by the guidelines and quality management process recommended by the Medical CE.

For us, medical certification is not simply a one-time tick in the box, but continuous development following our product evolution. When new features and use cases are introduced in our product, we evaluate the impact of these changes for patient security and product quality. It is built into our engineering process. Medical certification is also a signal to patients and healthcare professionals that we take quality, availability, and privacy seriously.

While regulations primarily exist to prevent devices from having a negative impact on the patient’s safety and data confidentiality, they also force you to think and document product usage, user experience, performance, and technical solutions from the patient’s point of view. This is all good for us as well, as it helps us build a better, safer product.

Medical CE for the Neuroeventlabs product is an important milestone for us as the product enters clinical use (our focus for this year). We are well on track!