_edited.jpg)
About
With over two decades of experience in medical device technology, Qualisure Consulting is headed up by Carlos Maline, who brings a unique combination of leadership, technical expertise, and regulatory knowledge to the rapidly evolving healthcare industry.
​
His career journey spans 19 years in the Royal Air Force, where he honed his skills in precision and discipline, followed by a tenure as Senior Client Manager at BSI, gaining invaluable insights into regulatory compliance and quality management systems. Most recently, as Senior Regulatory Affairs Specialist, Carlos is at the forefront of revolutionising healthcare through innovative Software as a Medical Device (SaMD) solutions.
​​
​
At Qualisure Consulting, we are dedicated to helping organisations navigate the intricate world of medical device regulations and quality management. Whether you're developing SaMD solutions or other medical technologies, our expertise in multi-jurisdictional regulatory conformity, risk assessment, and quality systems can provide the guidance needed to bring your innovations to market efficiently and compliantly.
We are passionate about driving innovation in healthcare technology and collaborating with professionals who share a vision for improving patient care through advanced medical software solutions. Let’s work together to shape the future of healthcare.
