6 months



Our client a major international Medical Device Manufacturer, headquartered in NJ, USA.



Their strategy was to establish a new manufacturing facility in Ireland to manufacture a neurological surgical device which had been purchased from the original product designer and manufacturer also located in the USA. The Irish facility was to be ready within 6 months to receive, manufacture and distribute the new product to the EU and USA markets.

The project contained many risks and the complexity required tight management and control. Project management expertise was an essential pre-requisite coupled with expert knowledge and understanding of the medical device GMP requirements for both electromechanical and sterile disposable products.



  • Establish a functional quality management system to meet various US and EU medical device regulations and quality policy of the company.
  • Ensure the quality management system obtains certification by designated Notified Body to allow sale of product in the EU.
  • Submit device technical file to Notified Body for review and approval
  • Ensure DMR is transferred to the Ireland, UK and Puerto Rico manufacturing facilities of the company.
  • Ensure all manufacturing activities are appropriately controlled and processes validated.
  • Participate in complex project management relating to the international coordination of activities at manufacturing facilities in Ireland, UK, Puerto Rico and the USA.
  • Provide personnel development and mentoring services.
  • Communicate with senior company management on progress and recommend technical, quality and regulatory strategy as necessary.



  • New Manufacturing plant set up in Ireland with supporting facilities in UK and Puerto Rico on time and within budget to manufacture and distribute finished product.
  • Quality management system approved without problems at initial Notified Body inspection to meet requirements of ISO 13485:2003 and the MDD 93/42/EEC
  • FDA Facility registration
  • UL Registration.
  • Handed over facility in excellent state of control to newly hired management, and thanked by senior corporate management for a project well delivered.