Monivent receives ISO 13485:2016 certification - Chalmers Ventures

Monivent receives ISO 13485:2016 certification

Monivent is a young medtech company dedicated to improve the emergency ventilatory care given to newborn babies in need of respiratory support at birth. About 3-6 % of all newborns end up in this situation, where healthcare personnel today are lacking tools to determine how effective this manual ventilation really is. This can result in two major risks; inadequate volumes causing insufficient gas exchange and failed resuscitation while excessive volumes can result in over-expansion of the lungs causing lung injuries as well as extrapulmonary injuries, especially in babies born very prematurely.

Monivent helps caregivers to make necessary adjustments to ensure an effective and gentle treatment during manual ventilation of newborns unable to breathe spontaneously. Their monitoring device is an add-on to existing manual ventilation equipment. The airflow is wirelessly measured directly in the face mask and feedback on several critical parameters, such as tidal volume, are continuously shown on the external display to guide the caregiver.

Read more about Monivent’s products here.


As a medical device developer Monivent is required to set up a quality management system in accordance with ISO 13485:2016, now reviewed and certified by RISE. A great milestone for the company and an important step towards launching the company’s first medical product later this year.

Monivent is a portfolio company to Chalmers Ventures