Cardiolife Appoints New QARA Manager

Cardiolife is strengthening its regulatory and quality leadership with the appointment of Luísa Silva as the company’s new Quality Assurance and Regulatory Affairs (QARA) Manager. In addition to this role, Luísa will also serve as Person Responsible for Regulatory Compliance (PRRC).

Luísa joins Cardiolife with more than 20 years of experience in management systems consulting and medical device regulation, specializing in ISO 13485, MDR (EU 2017/745), ISO 9001, ISO 14001, and ISO 45001. Throughout her career, she has supported a wide range of medical device manufacturers and distributors — including SaMD companies, medical and CSSD equipment, implant manufacturers, and global optical device brands — with responsibilities spanning regulatory strategy, clinical evaluation, internal auditing, risk assessment, and audit preparation.

Cardiolife CEO Kristin Lied emphasises the strategic importance of the appointment:
“We are delighted to welcome Luísa to the Cardiolife team. After collaborating with her as a consultant for several years, we know the depth of expertise and professionalism she brings. Her strong regulatory background and deep understanding of medical device quality systems will be invaluable as we scale. Luísa strengthens our ability to deliver safe, high-quality, and clinically validated AI technology to healthcare systems globally.”

Luísa holds a degree in Biological Engineering from Universidade do Minho and is certified across multiple medical device and quality frameworks. She has worked as a consultant in the industry for over a decade and co-founded Improve It – Consultoria, where she has supported organisations in quality management, regulatory compliance, and strategic development.

Reflecting on her new role, Luísa said:
“I am excited to join Cardiolife at such a pivotal stage in its growth. The company’s commitment to clinical excellence, innovation, and regulatory rigor aligns strongly with my own values. I look forward to contributing to Cardiolife’s continued success and supporting the team in maintaining MDR compliance while progressing toward FDA clearance.”