Heartbeat Research Group
The Heartbeat Research Group (HRG) consists of 8 members of the Heartbeat company who are specialized in science.
A unique feature of this group is that besides research experience all members are certified perfusionists and work on a day to day basis in the operating room of various hospitals.
Core values Heartbeat Research Group
All research is conducted under the responsibility of a certified principal investigator.
All research is carried out in one of our certified facilities.
- With the support of our two PhD’s we can provide companies with a diversity of study concepts.
What can we do for you
Post Marketing Surveillance (PMS)
In order to evaluate the quality and safety of medical devices we set up a database of medical devices used during CardioPulmonary Bypass (CPB). Besides, in the new European legislation Medical Devices Directive, which comes into effect in 2020, manufacturers are obliged to monitor the safety and performance of the medical device.
Medical device risk management is an ongoing process of review and risk assessment throughout the life of the device. Risk management procedure should be directly linked to the post market surveillance procedure and the requirement of the European Medical Device Directive. Post Market Surveillance (PMS) and vigilance are key tools in this process. Medical device companies need to show proof in the form of documentation and audit trail that medical device post market surveillance is being performed.
ISO 9001: 2015 - certified lab
Our lab and the following apparatus available for in vitro studies:
Perfusion pumps (roller and centrifugal), flow measurement, heater, precision pressure measurement, bubblecounter (GME, BCC300), capnography, online blood gas analyzer, POC blood gas analyzer (i-stat).
The possibility to obtain bovine blood and use this in our HRG lab.
With the support of our two PhD’s we can provide companies with a diversity of study concepts including ex vivo (optionaly with bovine blood) and also clinical studies, including multicentre clinical trials.