How the story begins

Initial research & development began in 2015 after Jos van den Berg was approached by the Erasmus Medical Center in Rotterdam to design and deliver a warm & cold-water supply for the Operating Rooms to manage patient temperature during cardiac surgery procedures. In previous years he had built experience designing and developing a wide array of very specialized refrigeration systems including Ultralow (-80 degree celcius) storage solutions as well as Magnetic Resonance Imaging (MRI) cooling which made him an established supplier to the Erasmus University in Rotterdam.


Jos consulted with Eelke Krijnen who has been in the Cardiothoracic Surgery market for 20+ years and came to the conclusion that there was a broader need for a new generation Heater-Coolers that could address the recently recognized issues in relation to the bacterial contaminations by conventional devices currently on the market.

The stricter cleaning protocols that were implemented in relation to the contamination issues meant manual cleaning with aggressive agents and deterioration of the longevity of the existing machines.

A broader project team was formed with Paul Verdonk (Electrotechnical Engineer) who acted as a trusted lead engineer in multiple previous development projects and Sanne Krijnen (Sales & Marketing, Medical Devices) which kickstarted initial conceptual phase.

Development activities lead to early functional prototypes resulting in founding Heater Cooler B.V. in October 2017 with the initial project members including Bastiën van der Hoeff who came on board to manage the Quality & Regulatory aspects of the company.

On the 8th of October 2021 CE Mark Approval (MDR) was granted on the system clearing the system for use in the European Union. Undoubtedly a tremendous achievement by a very small a dedicated team of professionals.

Certification

Medical Device Regulation (EU) 2017/745 certified.

The HCS-1 device is a class IIb medical device in accordance with Regulation (EU) 2017/745.
Approved for clinical use in the European Union.