Quality & Certifications
Where uncompromising quality fuels innovation.
Combining cutting-edge cardiovascular intelligence with rigorous quality systems and global standards to deliver safe, reliable insights when they matter most.
Our Ethos
Our commitments to excellence.
Quality is a discipline that runs through every decision we make, from device design to data delivery.
Patient safety
Putting patient safety and outcome improvement first.
Data integrity
Safeguarding data integrity, privacy, and cybersecurity.
Quality system
Operating a risk-based quality management system.
Continuous improvement
Fostering a culture of continuous learning and improvement.
Transparency
Collaborating transparently with all constituents.
Compliance & Standards
Held to the highest standards.
Prolaio’s quality systems meet the rigorous requirements of regulators and customers across the United States and globally.
ISO 13485:2016
Certified medical device quality management systems.
MDSAP
Certified single regulatory audit of a medical device manufacturer to satisfy the relevant requirements of ISO 13485:2016 and the regulatory authorities in the US.
21 CFR Part 11
Compliant with the FDA’s electronic records and electronic signatures standard.
Prolaio Quality Policy
Innovative by design.
Prolaio is committed to providing safe, effective, and innovative medical devices that improve patient care and satisfy regulatory and customer requirements through the implementation, continued maintenance, and improvement of a suitable, effective, and efficient Quality Management System.
QM-0003 · Version 1 · Released 2024-02-27