Certified in activities regarding: Design, development of Medical Devices and lvD Medical Devices. Risk Management and Usability Engineering activities. We celebrate our certification to ISO 13485: 2016, the international standard for medical devices. It is a long-awaited update from the well-established ISO 13485: 2003. We have been working on implementing ISO 13485: 2016 […]
“Please explain Test and Verification in simple terms” – we get this question quite often. A great part of our work at Technolution revolves around building robust test methods. That are focused on generating knowledge and insights early in the development process of medical devices. The foundation for working with medical device test methods is […]
Lars Eilertsen has a master’s degree in mechanical engineering from the Technical University of Denmark (2003). After working in the office furniture industry, he joined Technolution for six years where he worked on assignments for Radiometer, Coloplast and Novo Nordisk. Now Lars has returned to Technolution after seven years at Novo Nordisk, where he […]
Deciding on whether or not you should invest in Augmented Reality today, is not easy. If you get on board too soon, you risk investing in something the world is not yet ready for. Getting on board too late and you’ll risk losing your market or growth potential. We know, it’s not easy! But, perhaps […]
It is the common understanding that engineers are not the most talkative and extrovert of people, myself included. Many of you probably know this joke, but I will tell it anyway because it is right to the point. “How do you tell the extroverted engineer from the introverted engineer?” “The extroverted engineer is looking […]
Marianne graduated from DTU in February 2018 with M.Sc. degree in Design and Innovation engineering. Marianne did her thesis in collaboration with Velux focusing on lifetime robustness of windows. Marianne has previously worked at Technolution as student assistant and later as R&D engineer. Here she gained experience in test method development and documentation as […]
Facilitation is key to bringing fresh perspectives into common design and engineering tasks. It has been shown to improve creativity, decision making, team cohesion and overall performance. Workshops that are not facilitated properly often result in unmotivated participants and an output with too narrow a solution space and too little innovative ideas. To help […]
Kasper has just finished his master’s degree in Engineering Design and Applied Mechanics at DTU. He wrote his thesis in collaboration with Velux in the field of Robust Design. The aim was to develop and validate a numerical calculation model to determine wear in sliding bearings with regards to Reliability Engineering. In 2015 Kasper […]
You have an idea for a new product. It is actually great and you think to yourself: ‘If I find this useful surely others will, too. People even say they can’t wait to get their hands on it. Let’s do this!’. That is great, and I’m rooting for you, just be prepared to hit some […]
We are very pleased to announce that Thomas Bach Agerslev has been appointed as member of the board at Technolution. He has more than 20 years of experience within business process optimization, organisational development and strategic implementation. These are competencies which he has developed across several industries and businesses. They are of great value to […]
The medical Device Companies – and especially a lot of their Quality/Regulatory Affairs departments – hoped, right until the end, that the updated 13485:2016 standard would be merged with the new 9001:2015 approach and structure. A common approach supporting the entire company and all its processes – internally as well as externally. ISO9001:2015 – […]
The company Technolution are the first in history to have received the highest class of approval for medical products, the class 3, for an app. The product has been developed in collaboration with a major software company, which is yet to be revealed. It is a mobile phone implant with a pre-installed app, which is […]
Anders Elmer Jensen earned his B.Sc. degree in Mechanical Engineering from The Technical University of Denmark (DTU/DIA-M) in 1990, with focus on Mechatronics. With 27 years of experience from development and production companies, Anders joins Technolution as Senior Development Engineer. He has solid skills and insight into all facet of industrial product and machine […]
The need for a better tool. Planning a usability study – especially in medical device development – can be a cumbersome experience. Decisions need to be made on what to study and why, who to involve and why, and how to collect, treat, interpret and present data. Of course, all of this will be collected […]
Introducing the Usability Blueprint. Designing a usability study involves people from many different fields. Often, we see designers, anthropologists, UX professionals and QA specialists working together to cover all crucial aspects of the usability study. Based on experience from designing and planning multiple user-involving studies, we saw the need for a tool to easily facilitate […]
Morten Purup Andersen has a M.Sc. degree in Engineering Psychology from University of Aalborg, focusing on human interaction with User Interfaces. Morten is experienced in Usability Engineering and development of medical devices, software and IT, along with documentation and Design Control according to ISO 13485, IEC 62366-1:2015, ISO 14971, and FDA’s Human Factors Guidance. Morten […]
We’ve collected a bunch of interesting new medical devices that we find inspiring. Perhaps you will too. Enjoy the gallery above and/or the list below! 1: FUTEK’s QTA141 Micro-Reaction Torque Sensor QTA141 is a compact torque sensor with a small footprint of 22 mm in diameter and 10 mm in height. It can […]
Once again, we are scaling up on our task force in Quality Management and Design Control for medical device development. Our new Quality Management System Specialist, Anne Mette, will help us further develop our ISO 13485 certified Quality Management System (QMS). Not only will this benefit our colleagues, our clients who use and adopts our […]
The 3D-print technology has come a long way in the medical industry. Today we can expect far more than the classic plastic prototypes from the development process. There are rumours of mass production, but we’re not there yet. At least not in terms of large scale production of medical devices. The hype has vaporised and […]
You are reading the third part of an article trilogy about Design of Experiments (DoE). The trilogy covers the why, when and how to perform virtual DoE in the design process. By following these guidelines, you will experience a faster, smarter and cheaper way to get results that are vastly more reliable and ultimately a greater chance of succeeding […]
You are reading the second part of an article trilogy about Design of Experiments (DoE). The trilogy covers the why, when and how to perform virtual DoE in the design process. By following these guidelines, you will experience a faster, smarter and cheaper way to get results that are vastly more reliable and ultimately a greater chance of succeeding with […]