May 18, 2023 | Medical Devices, Verification and validation
The new European regulations are generating a lot of commotion. And this, what is it due to? In this article we want to tell you what the new regulations say regarding the validation and verification of software in medical devices under the new MDR/IVDR european...
Feb 6, 2023 | Medical Devices
The new European regulations MDR (2017/745) and IVDR (7017/746) are based on a series of harmonized standards. In this article we will delve into the harmonized standards for obtaining the CE marking of our medical or in vitro software-type product. The following...
