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Mechanical engineers discussing DoE - MedTech Development

The engineer’s guide to Design Control

When developing medical devices many challenges must be overcome but Design Control does not have to be one of them. Design control is a set of quality practices and procedures incorporated into the design and development process to control the design process and assure that device specifications meet user needs and intended use.    […]

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Bussy day at work

Implementing an effective Risk Management process

Identifying, estimating, and evaluating your device risks at the right time will increase the quality and safety of the device and can motivate the project members. Furthermore, it adds value by decreasing the project risks and avoiding costly late-stage changes. An effective Risk Management process is mandated by regulatory authorities (21 CFR 820 and 93/42/EEC […]

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A checklist for better product requirements

Design Input – agreeing on what to design Development projects are complex and often the team is not even in the same location. Writing unambiguous and specific design input requirements are of the utmost importance. According to a study that included large, medium, and small companies (incl. healthcare), opinions about why projects are impaired and […]

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Usability engineers discussing findings - MedTech Development

Why is Usability Engineering important?

Save time and money by focusing on Usability Engineering For some, it might seem obvious that for a product to be successful, the User Interface needs to be easy, safe and effective for the users to use, which requires a dedicated focus on designing and evaluating the interface. For others, it might seem excessive to […]

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Human Factors study notetaking

Planning your Usability Engineering activities

Why plan your Usability Engineering activities? What is User Interface Evaluation planning and why should you make an evaluation plan in the beginning of your project?   Most larger projects begin with a detailed plan, which is then updated as the project progresses. This is an important tool to ensure progress and movement in the […]

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Gaining the benefits of integrating Usability Engineering, Design Control, and Risk Management

Getting your device faster on the market by integrating separate processes In many projects Usability Engineering, Risk Management and Design Control are three separate processes. Though this is partly true, there are also lots of overlap and dependencies between them. This article briefly describes how you can integrate these activities to increase the chance of […]

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ISO 13485:2016 certification received

  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 […]

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How to test and verify your medical device concept

“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 […]

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A warm welcome to Lars

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 […]

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Should you invest in Augmented Reality today?

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 […]

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Marianne von Freiesleben

A warm welcome to Marianne

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 […]

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Get more and better ideas, faster

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 […]

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A warm welcome to Kasper

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 […]

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Thomas Bach Agerslev

Thomas Bach Agerslev joins Board of Directors

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 […]

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ISO13485:2016 - The Story of Narcissus

ISO13485:2016 – The Story of Narcissus

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 – […]

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iAgent

App Approved as Implant – First Time Ever

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 […]

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