A medtech firm executed a quality-system remediation program and prepared for a special regulatory audit in a short time frame.
Compliance with quality regulations is a growing issue in medtech, with an increasing emphasis on quality-management systems (QMS). Due to noncompliance, one European medtech company was at risk of losing its International Organization for Standardization (ISO) certification and, therefore, the right to sell its product. The firm needed to implement corrections and corrective actions across the quality system in less than two months to address regulator concerns and keep the ISO certification.
BCG project managers were assigned to client team leaders to help manage work streams, identify any bottlenecks in document control and training execution, and execute plan elements, including organizing and assembling proof books. A project governance plan was implemented to track program progress and manage work stream interdependencies.
As a result of BCG’s collaboration, the medtech company successfully addressed important regulatory issues, passed the audit, and maintained ISO certification. More than 60 procedures were revised and target audiences were trained on the new standard operating processes.
The QMS for a medical device company comprises several sub-systems: