MDR certification for tobacco cessation solution

Important results from the project

The purpose of the project was to establish a robust Quality Management System (QMS) compliant with ISO 13485:2016 and MDR, train a competent PRRC, develop necessary technical documentation, and prepare for medical device certification. These goals aimed to streamline regulatory compliance processes, enhance operational efficiency, and ensure the company´s readiness for certification.

Expected long term effects

The project resulted in the successful implementation of a functional QMS, significantly reducing time and effort spent on regulatory compliance. Tomas McKenna is now well-equipped with the knowledge and competence required for his role as PRRC. The technical documentation was developed to meet regulatory standards, preparing the company for future certification. The expected effects include enhanced operational efficiency, improved corrective actions, streamlined compliance processes, and improved readiness for certification.

Approach and implementation

The project was well-designed and effectively implemented, with clear objectives and structured support from QAdvis. The step-by-step approach to establishing the QMS, combined with thorough training for the PRRC, ensured comprehensive coverage of regulatory requirements. The integration of expert guidance facilitated smooth navigation through the complex compliance procedure. The practical implementation of the QMS has already demonstrated its value by saving significant time and effort within the company.