fbpx

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 […]

Read More

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 […]

Read More

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 […]

Read More

A warm welcome to Tobias

Tobias has a degree in marketing from Niels Brock business college of Copenhagen. Tobias has 2 years experience in marketing from the builder’s merchant industry, working for Saint-Gobain Distribution Denmark’s sub-brand Optimera.   During his 2 years in the marketing department at Optimera, he was responsible for their SoMe marketing, video productions, catalogs, and digital […]

Read More
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 […]

Read More

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 […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
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. […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
Marianne Lind

Welcome Marianne

Marianne is an expert in quality systems – ISO9001, AS9100, the Medical Device Standard ISO13485, including the Special Design Control Process in Medical Device Development and has worked with quality systems in the last 15 years. Most recently for 10 years at Coloplast. Marianne has also worked extensively with validation – processes, clean rooms and […]

Read More