Ceca Magán Abogados is providing free legal advice on The Open Ventilator development, with first units having been successfully tested and already sent to Madrid hospitals for more trials
The ventilator developed by The Open Ventilator in just over two weeks with a massive R&D effort has successfully. passed its testing in clinical trials for compassionate use, It has done so, moreover, demonstrating its ability to withstand intensive use and with the necessary medical parameters to safeguard the health of the most severe patients of COVID-19.
This device is almost equivalent to the already approved commercial respirators and not a mere portable or field ventilator, as those used these days as an emergency solution. The device has a Machine Learning device that allows it to learn and adjust to medical needs.
The process has required solving a complex legal network from both the business and medical point of view, for which they had the support of law firm Ceca Magán Abogados, with a team of experts assisting on the project as part of their pro bono cases.
Ceca Magán lawyers have provided legal advice on the launch of this health prototype, offering and providing guidance related to the provision of the respirator for its production and subsequent use in hospitals. Even with a legal gap, in this case, it has been possible to identify some procedures that, together with the Administration will, can make its use possible by guaranteeing, after the approval of the corresponding clinical trial, the health and safety standards required by regulations.
The objective is to provide both the Community of Madrid, which has invested in the project and the rest of the Spanish Communities without distinction, with a robust and functional device, designed to help health personnel and save lives. Production is expected to reach between 50 and 100 units per day in order to solve the serious shortage problem both in Spain and in the rest of the world.
The next step will be the green light to its mass production at a cost ten times lower than the current ventilators on the market. Ceca Magán advising team was formed by Public & Regulatory law partner María José Rovira (pictured centre), Litigation & Arbitration partner Emilio Gude (pictured left) and IT director Mónica Muñoz (pictured right).