A Return to Quality

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.

Inside the Quality-Management System

The QMS for a medical device company comprises several sub-systems:

  • At the center, management is responsible for determining policy and procedures, organization, responsibilities, resources, reviewing the adequacy of the QMS, and planning.
  • Some subsystems relate to how the product is made and how equipment, parts, and traceability are controlled.
  • Design controls ensure that the product is designed to meet user needs.
  • Document controls govern how quality records are kept and maintained over time.
  • Corrective and preventative actions is the part of the quality system that detects issues and determines how to address them.
  • Risk management is an overarching framework for how the company characterizes risk—as in the frequency and severity of an event occurring—and how to take action according to the level of risk.
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