Each individual’s brain is unique – brain scan analysis is even comparable to a fingerprint or a QR code. However, diagnosing brain injuries is often complicated. The service developed by Myndspan enables scientific proof of brain injuries or other diseases…
This blog post delves into the primary distinctions between the EU and US approaches to Quality Management Systems (QMS) in the medical device industry. The world is global—this much is true. However, not all things are equal, even if they…
Diagnosing concussions is complicated, as it is often based on the patient's subjective experience. Atostek has been involved in developing a platform that enables reliable concussion diagnosis. In addition, Atostek's medical device know-how played an important role throughout the development…
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…
This fall, Atostek will head towards the United States and the local medical software development market. For this purpose, the company has hired a top specialist with extensive experience in North America, regulations and health technology. The person headed to…
By medical device we mean, for example, a device, software or instrument that is used to diagnose or treat patients. The software itself may be a medical device, or software can be used to control the operation of a medical…
