Quality Management MedTech – Internship
Title: Contribute to building the Technical Documentation to comply with the Medical Device Regulations of EU and USA
About MDsim
MDsim is a MedTech start-up based in Luxembourg advancing the field of in-silico medicine. Our main product, SPINEsim, is a Software as a Medical Device (SaMD) designed to transform spine health and improve the planning of surgical procedures. By combining advanced computer modeling and simulation (CM&S) with the power of data science and AI, we create digital twins of the spine to support clinical decisions. Our mission is simple yet ambitious: to bring proven technologies into healthcare and improve the quality of life of patients with spinal deformities worldwide.
Project objectives
• Contribute to implementing new and enhancing existing Quality Management System (QMS) processes including their deployment and usage within MDsim teams.
• Contribute to obtaining and maintaining the authorizations to go-to-market in EU and USA and other markets, through the preparation of a solid Technical Documentation demonstrating to authorities the safety and performance of MDsim medical devices. The student(s) will contribute to 1 or more sections of the Technical Documentation such as Risk Management, Software-Tools validation, and clinical evaluation.
What you will learn
• Get familiar with the QMS of a medical device and learn about EU and USA regulatory strategies for market authorization.
• Be part of the Quality & Regulation team of a MedTech start-up.
Main deliverables
Enhancing and maintaining the QMS and the various ISO and Regulatory Certifications.
Your Profile
• Highly motivated with a “can do” attitude.
Additional Information
• Internship should be for 3 months minimum.
• Remote work is partly possible, but on-site presence in Luxembourg is preferred.
Leave a Reply