With more than 20 years of experience within Medical Devices, Trine is passionate about ensuring that the Quality Management System is a practical, strategic advantage and competitive parameter for the client’s business. On a daily basis, Trine uses her broad expertise within Quality Management, QC, R&D, Engineering, Production, Supply Chain, LEAN, general management and Change Management. Trine specializes in creating business oriented, practical and efficient quality management processes by ensuring process ownership. Trine holds a Bachelor of Engineering in Production from DTU Ballerup. Trine also has an ISO Lead Auditor background from which she has obtained solid experience with Business ISO Certificate Approvals, Internal-, Supplier- & Customer Audits and 3rd Party Inspections (ISO and FDA). Trine has also gathered documentation packages and got MDR and IVDR approvals at Notified Bodies. So, if you are looking for practical solutions, support and implementing or updating management systems and processes, gab analysis, or NB documentation packages, contact Trine for an introductory talk.