Liaison(s): Tami Tuttle
Medtronic is a large sized medical device company that focuses on four main business units: 1) Minimally Invasive Therapies Group, 2) Diabetes Group, 3) Restorative Therapies Group, and 4) Cardiac and Vascular Group. Medtronic has developed therapies to treat more than 70 conditions in the human body, some of which include: airway and lung, brain, diabetes, digestive, gastrointestinal, uro-gynecological, urological, ear, nose, and throat, heart and vascular, pain, spine and orthopedic. Medtronic’s Team Master’s Project (TMP) focuses on the Restorative Therapies Group, specifically Brain Therapies.
As a medical device manufacturer, Medtronic needs to abide by all applicable US and International regulations to ensure compliance with the regulatory requirements of the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), and others. One of these requirements is the effective establishment and management of a Quality Management System (QMS) to ensure that all products and processes are being produced and carried out in accordance to Good Manufacturing Practices (GMPs).
Medtronic has seen large growth over the recent years partly due to company acquisition and utilizes multiple manufacturing facilities to produce their products. Each manufacturing facility manages its own unique certified QMS that includes some shared corporate or group level procedures. The company must try to manage several quality systems while ensuring product integrity and regulatory compliance. The purpose of the Medtronic TMP is to analyze the QMS for two sites and compare the following quality system processes Control Nonconforming Material, Manage Compliance, Manage Quality System, and Manage Risk. Additionally, the team has developed a harmonization model which informs project planning of the resources and costs associated with integrating the quality systems.