March 23, 2026
Founded in Iceland in 2007 by Gudmundur Fertram Sigurjonsson, Kerecis was established to develop and commercialize the innovative concept of using fish skin to heal damaged tissue. Since then, the company has achieved ISO13485 and MDSAP Certifications, CE marking and U.S. regulatory clearance for its portfolio of fish skin products, with plans underway to expand into additional global markets and add new device types to its portfolio.
Since 2024, MD Compliance has supported Kerecis by providing a range of specialist consulting services, including MDSAP mock auditing, internal auditing, and strategic guidance on design process, risk management, and environmental controls.
As part of our collaboration, MD Compliance was commissioned to develop and deliver a structured RAQA training program for the Kerecis team represented at all key functions in the organization. Our Senior Consultants developed a series of remote training modules covering EU MDR requirements, Risk Management, and introduction to ISO 13485 / U.S. FDA QMSR.
To ensure long-term value, Kerecis explained that the training program had to be designed to be scalable and reusable, incorporating recorded training sessions, post-training assessments, and personalised certification. This approach allows Kerecis to continue using the materials to train new hires as the company grows.
Ina Ossurardottir, Director of Quality Assurance at Kerecis, commented: “MD Compliance was the ideal partner for helping us establish our RAQA training program. They were flexible in their approach and able to quickly allocate highly experienced consultants to lead the training session. It has been a pleasure working with the entire MD Compliance team and having someone you can count on in your corner.”
