Atostek has signed a global partnership agreement with an American company Tala Secure. Together, the two companies offer a 1-stop-shop software resource for medical device companies and institutions with integrated and connected healthcare needs. The purpose of the cooperation is…
The development of a medical device or software is regulated in Europe by the Medical Device Regulation (EU 2017/745). Then again, MDR does not really involve much extra work to software development – compared to what it should be anyway.…
What are the most important things to consider in planning and implementing effective and standard-compliant testing of medical software? By medical device we mean, for example, a device or software that is used to diagnose or treat patients. The software…
Usability is an important part of each and every piece of device and software. When human health is concerned, it is even more crucial. The IEC 62366 standard helps manufacturers ensure that usability is factored into the development process of…
