9 months (US & Switzerland)



Our client a major international Medical Device Manufacturer, headquartered in NJ, USA, with manufacturing locations globally.



The project was to coordinate quality system remediation across multiple facilities following a Consent Decree agreement with FDA.



Reporting operationally to the clients Director of Quality Management Systems Development, we managed a team of external consultants and other client personnel engaged on the development of Remediation Protocols to control and manage the implementation of remediation activities in a systematic way relating to major Corporate CAPAs concerning:

  • CAPA
  • Corrections and Removals
  • Quality Planning
  • Risk Management
  • Quality Metrics
  • Internal Audits

In addition, we directly coordinated Quality System Management Review and Quality Data Analysis for the EMEA facilities of the client. This project required systematic communication with 12 facilities and approximately 60-80 personnel located in Switzerland, Austria and Germany. The project required clear and defined reporting of progress to both the US and EU HQ’s.
Our major outputs were objective and critical analyses of deficiencies identified with the conduct of QS Management Reviews, and the provision of accurate and meaningful data analyses of key quality data sources for a three-year period.



This project was delivered successfully and on schedule and allowed senior executive management to perform critical and objective "legacy" QS Management Reviews for each facility to determine if any unidentified risks existed that would require implementation of actions to improve safety, effectiveness and quality of medical devices and improvement with US FDA regulatory requirements.