Our engineers will help you solve complex mechanical, electronics or software challenges to deliver creative and robust medical devices.
Our Mechanical Engineering team is intimately aware of the demands laid upon your future product. First of all you need to have a viable business case. You also need a short time-to-marked. Especially relevant are the regulatory requirements and standards. They impose strict requirements for the development and approval of Medical Devices. And in addition, you must ensure that the end-user finds your product appealing.
We have years of extensive experience working with medical device development. And we have done so for several of the nation’s leading medical device companies. As a result, we are at the forefront of the unique demands of Medical Device development.
This involves mechanical engineering, risk management, quality, regulatory affairs and documentation. This is what we do.
Consequently, you will gain access to our expertise and a complete structure, facilities and tools. We have designed these specifically to ensure, that your product will go to marked successfully. Therefore we are working with a proven development model. You will reduce both the costs and the expensive iterations during the production process.
Get it right and get there fast.
Because we help you spot errors and false assumptions early on, you reduce the risks of corrections during production. You will at the same time be provided with proper validation of decisions throughout the process.
We continuously build “best practices” for processes, activities and documentation. And we implement them in our own quality management system.
Therefore, you are well on your way to a successful product launch, when you decide to take Technolution on board.
Finally, we can provide individual resources as well as complete development teams. This applies to the development of Medical Devices according to ISO 13485 and MDD / IVDD, consumer electronics, products and systems in the Clean Tech industry.
Due to our ISO 13485 certified quality management system (QMS), Technolution can handle the entire process. We are with you from idea to finished product and CE marking. Our quality management system ensures high quality and efficiency in our services, whether projects and activities are taking place on the clients’ premises or Technolution’s premises.
Benny MathiassenHead of Mechanical Design / Coloplast
Technolution has introduced us to new methods of development that will increase the efficiency of our mechanical development team.
- Technology Assessment
- Feasibility studies
- Design review
- Idea generation
- Design integration (design, mechanics, electronics, chemistry, etc.)
- 3D mechanical design
- Robust design
- Design for Manufacturing and Assembly (DFM & DFA)
- Cost optimization
- Tolerance Analysis
- Simulation (FEM and Mold Flow)
- Rapid Prototyping
- Material selection
- Technical documentation
- Test and verification
- Standardization, modularization and product architecture
- DoE – “Design of Experiments”
- Injection Molding
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