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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Anders Elmer Jensen

A warm welcome to Anders

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 […]

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A Better Tool for Planning Usability Studies

A Better Tool for Planning Usability Studies

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 […]

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Morten Purup Andersen

A warm welcome to Morten

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 […]

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Inspiring medical devices

  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 […]

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Improove QMS and boost Design Control

Improving QMS and boosting design control to reduce time-to-market

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 […]

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3D printed babies

The future is now – 3D printed babies

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 […]

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DoE 03

How you should apply virtual DoE in the design process

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 […]

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When you should use virtual DoE in the design process

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 […]

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Why you should apply virtual DoE to the design process

You are reading the first 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 […]

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Handover

Technolution prepares for a handover

A generational handover can be a huge challenge for many companies. Especially, when the company’s success is closely linked to the owner’s personal network. In Technolution, we have chosen to make all employees co-owners today to ensure a future handover within the next 5-10 years. The board has been working strategically for several years focusing […]

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Jon Storm Madsen

Jon Storm Madsen – Partner and Head of Usability

Jon is responsible for Technolution’s usability, and at the same time has a broad profile as an R&D engineer. He is a project manager, a developer and contributes with a combination of specialist functions within usability, user testing and user involvement. Jon makes sure that users are consulted when Technolution develops new products within medico […]

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Anders Grove Sund

Anders Grove Sund – Partner and Head of Test and Verification

Anders is responsible for Technolution’s testing and laboratory activities, ranging from proof-of-principle to Design Verification. He works within robust design, both as a mechanical and test developer. Anders helps Technolution’s clients develop test methods and equipment, set up tests, as well as data analysis. He focuses in particular on the experiments supporting the progress of […]

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Peter Werner Hansen

Peter Werner Hansen – Partner and Project Director

As Project Manager Peter’s primary responsibility is to execute the projects, “and make sure we are getting somewhere” as he says. He is an expert in materialising products and product development processes, with a broad experience in project and team management. Peter has helped bring more than 200 products to the market. Internally, he is […]

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Kasper Friis

Kasper Friis – Partner and Head of UX and Design

Kasper is responsible for user experience and design and that the products Technolution develops, meet users’ needs throughout the user interaction and across platforms, both physically and digitally. Interaction design is not just about user efficiency, but also to make sure the product actually brings new value into the users’ lives – in all situations. […]

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Michael Tokeskov Mikkelsen

Michael Tokeskov Mikkelsen – Seniorpartner, Project Director and Head of QA/RA

Michael is responsible for the development of Technolution’s services within Quality Assurance (QA) and Regulatory Affairs (RA), which is an area of continuous growth. Michael has extensive experience in developing medical devices and works primarily in the border area between R&D and QA, e.g. preparing QA strategy and documentation. In addition, he coordinates the cooperation […]

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Shareholders

Technolution has made employees co-owners to ensure future growth

Technolution A/S is an engineering company that offers consultancy and innovation to the medical industry. The management has now decided to offer all employees co-ownership. The purpose is to develop, maintain and attract the much sought after medico skills that are crucial to the company’s future development. Health technology has a high growth potential. Technolution […]

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Morten Bæk Nielsen

Welcome to Morten

Morten is a newly graduated engineer M.Sc. from DTU, where he made his thesis on robust design. The thesis was conducted in cooperation with Radiometer and aimed at developing a tool that gather and present information on robustness for a product. Morten has previously worked as an intern at LEGO, where he was part of […]

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FDA AI requests

New forces in regulatory affairs eases the approval process for medical devices

As shown in the graph above, only 31% of all 510(k) applications (Premarket Notifications) goes through the approval process without a request for ‘Additional Information’ (AI) from the US approval authority; U. S. Food and Drug Administration (FDA). This figure clarifies and emphasizes the bureaucratic and often confusing approval process that all medical devices must […]

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