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 commitments to excellence

Putting patient safety and outcome improvement first

Safeguarding data integrity, privacy and cybersecurity

Operating a risk-based quality management system

Fostering a culture of continuous learning and improvement

Collaborating transparently with all constituents

Compliance & standards

21CFR Part 11

Compliant with the FDA's electronic records; electronic signatures standard

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

Our certifications

ISO 13485:2016 Certified

ISO 13485 is an international standard that sets out the requirements for a quality management system specific to the medical device industry. ISO 13485:2016 is the latest update to the ISO criteria maintained for effective quality management system practices.

View certificate

MDSAP Certified

To achieve MDSAP certification, manufacturers must modify their Quality Management System to meet MDSAP requirements, implement any changes, conduct employee trainings and provide updated design documentation.

View Certificate

Prolaio quality policy

Prolaio is committed to providing safe, effective, and innovative medical devices that improve patient care and meet or exceed regulatory and customer requirements through the implementation, continued maintenance, and improvement of a suitable, effective, and efficient Quality Management System.

QM-0003, Version 1

Release Date: 2024-02-27