Trine has quite a diverse professional background. Apart from a 3-year break as an office manager, she spent 17 years in the advertising industry as an account manager at various agencies. After having her children, she decided to shift lanes and took on different positions first in real estate as an office assistant and […]
Signe Uhre Guldfeldt holds a Chem. Eng. from Aalborg University, an EBA from Copenhagen University and has several certificates as Lean Silver Sensei, PRINCE2, Project Leadership coach, Black Belt in Quality Function Deployment (QFD) and PROSCI change management. Signe has more than 20 years of experience within compliances in program/project management and business optimization […]
Bjarke graduated from Aalborg University with a MSc in Industrial Design in 2014. His Master Thesis concerned the development of a new hospital bed with a built-in laminar airflow curtain designed to prevent the spread of Hospital Acquired Airborne Infections. This involved both computational fluid dynamics, to ensure an even laminar flow, as well as […]
Simon is currently studying Medicine and Technology a collaborative degree run by the Technical University of Denmark (DTU) and the University of Copenhagen (KU). He started studying in 2015 and have spent a sabbatical year serving as a professional soldier. Through his education, Simon has had study jobs at a large Medical Device manufacturer in […]
Sophia Troldborg Ohmann recently finished her master’s degree in Biomedical Engineering from the Technical University of Denmark. She wrote her thesis in collaboration with Coloplast A/S, designing and developing prototypes of an assistive device to accompany one of Coloplast’s existing devices to expand the user group of the device. To test the safety, effectiveness, and […]
Mike is currently finalizing his MSc in Design and Innovation at the Technical University of Denmark, focusing on Usability Design as well as Sustainable Product and Systems Design. While studying, he has been working as a Mentor in Mathematics for high school students at MentorDanmark. Partnering with a fellow student, he wrote a Bachelor Project […]
Mathias obtained his MSc degree in Design and Innovation from DTU in 2018, where he focused on mechanical product development and conceptual design. For the past two years Mathias worked at KiteX IVS, a start-up specializing in wind energy and drone technology. As part of a small and dynamic international team of engineers from […]
Nicklas recently finished his master’s degree in Design & Innovation from the Technical University of Denmark. He has written his thesis on ServedOnSalt, a start-up which he is the co-founder of. The thesis was a technology and product development project on a thermal salt heating appliance for clean cooking in developing countries. In the project, […]
Kasper graduated in 2013 from the Technical University of Denmark and holds a Master of Science in Engineering, Design and Innovation. Kasper’s thesis explored the possibility of bridging the gap between the needs of Danish healthcare professionals and the solutions of Danish MedTech companies through an online knowledge-sharing platform. Kasper started his career as […]
Linnea finished her master’s degree in Biomedical Engineering from the Technical University of Denmark (DTU) in 2019. In her master’s thesis she implemented an algorithm for automatically detecting coronary arteries in computed tomography angiography images. This was done with the purpose of detecting constrictions of the coronary arteries due to atherosclerosis. After finishing her studies […]
Lisbeth holds a master’s degree in Design & Innovation Engineering from the Technical University of Denmark. Her thesis was conducted in collaboration with Radiometer and the Danish Institute of Medical Simulation and explored the benefits of using medical simulation to conduct high fidelity usability testing of medical devices. After graduating in the Spring of 2014 […]
Tanja Victoria Brenek brings solid Medical Device Quality Process Management experience, combined with a Management- and Project Management degree. Tanja has extensive experience managing global quality processes with 800+ users, and global projects such as transferring processes to new platforms. She has worked within the areas Quality Process Management, Quality Systems, Post Market Surveillance, […]
Christoffer graduated in the beginning of 2014 and now holds a Master of Science in Engineering, Design and Innovation from the Technical University of Denmark. During his master’s, he and a fellow student established the company CutLab CPH – a creative production and design company that specializes in digital fabrication and the development of […]
Christoffer is currently studying Design and Innovation (MSc) at the Technical University of Denmark where he is focusing on complexity management and sustainable engineering systems design. Alongside his studies he has been working as a Teaching Assistant in the courses Technology Analysis and Holistic Design of Engineering Systems. He has previously worked with human-centered […]
Pelle recently finished his master’s degree in Design & Innovation from the Technical University of Denmark. He did his thesis in collaboration with LINAK, focusing on modular platform-based product family design, aimed at reducing product and production complexity in large scale and mass customizable productions. During his studies, Pelle worked as development assistant and […]
What is important to you as a medical device project manager, is that the aim of the update is not to revise the risk management process, but rather to improve the information on implementation of the risk management process Why update ISO 14971:2012? A working committee group has been working on updating the risk management standard ISO […]
Numerous usability evaluation methods exist in which you do not need to perform in-person usability testing. When designing the user interface for a medical device, the US FDA and other authorities expect you to use these methods in addition to in-person usability evaluations. Desk analysis methods are complementary to actual in-person usability evaluations. Often, […]
Our experienced team has assisted several MedTech companies in developing design control documentation that brings value to the project and the product and is consistent across the entire documentation, including labelling. Design Control through a development project is about overview, experience with product development, planning and of course preparation of documentation at a necessary […]
Nancy Eben Fonskov holds a Master of Science in Mechanical Engineering from Aalborg University in year 1995. Nancy possesses strong quality assurance and business knowledge within the Medical Devices and Pharma Industry. She has worked with Medical Devices and Pharmaceutical Packaging within the areas Quality Management, QC, R&D, Sourcing, Warehouse, Engineering and Production for […]
Mathias recently finished his master’s degree in Biomedical Engineering from Technical University of Denmark. His thesis focused on developing a robust and versatile method to 3D map local oxygen concentrations in artificial tissue with non-invasive means. The project was multifaceted and incorporated expertise within product development, mechanical engineering, and advanced statistics. Mathias has previously worked […]
Kristian Amdisen graduated in 2017 from DTU and now holds a M.Sc. in Engineering Design and Applied Mechanics. During his master studies, Kristian has focused on numerical modeling and product development, giving him a strong skill set in this area. For the past year and a half, Kristian has worked for Koenigsegg Automotive, working […]