Jako Pranger

Jako Pranger currently serves as the QA Manager at Cardialysis, where he leverages over 15 years of extensive experience in the medical device industry and contract research organizations to uphold the highest standards of quality and compliance. In his role, Jako oversees the development, implementation, and continuous improvement of quality management systems aligned with international standards such as GMP, GCP, and ISO 9001. His expertise is instrumental in ensuring that Cardialysis’s innovative cardiology solutions meet rigorous regulatory requirements, including CE marking and other global compliance standards.

A key focus of Jako’s work involves leading audits and providing consultancy services to both internal teams and external clients, ensuring adherence to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and other regulatory frameworks. His strategic initiatives include the validation of computerized systems, statistical programs, and core lab techniques—crucial components in clinical trials and medical device manufacturing—ensuring these systems operate reliably and in compliance with international requirements.

Jako’s major achievements include establishing and expanding the company’s quality system to achieve ISO 9001 certification, which has significantly enhanced operational efficiency and product quality. His deep understanding of computer system validation, quality assurance, and regulatory pathways in cardiology devices positions him as a vital contributor to Cardialysis’s mission to deliver safe, effective, and compliant medical solutions. Through his leadership, the organization continues to strengthen its quality infrastructure, supporting successful clinical trials and regulatory submissions worldwide.