Device Engineering and Industrialization

Design & Development for Manufacturing and Assembly 

Valtronic provides device engineering expertise to design and develop manufacturable devices of the highest quality.

From Idea to a Manufacturable Product

Any brilliant idea for a new device or for the improvement of an existing one requires design and development expertise and experience to turn it into reality. Why? Because many challenges arise if you do not have the in-house expertise and capabilities to think ahead and include manufacturability in your project. Valtronic’s experienced and highly skilled engineering team provides the expertise and out-of-the-box thinking you need to help you design your device from scratch or to review the design of an existing device to reach the next level of innovation. From feasibility to customized solutions, we provide all the capabilities needed to design and develop a manufacturable high-quality device.

Device Engineering Teams 

The highly qualified Valtronic engineering team has developed design, testing, and qualification processes for various and complex devices. As soon as they onboard a new project, they apply methodologies such as Design for Manufacturing and Assembly (DFMA), Design for Testing (DFT) and New Product Introduction (NPI) to make sure all critical functionalities of your product will be addressed.  In addition, they work in close collaboration with Manufacturing and thus know all of the stringent constraints inherent to device of the highest quality. Also, they immediately perform a thorough BOM analysis together with our Supply team to ensure optimized supply throughout your product life cycle. And finally, they work from scratch with our team of quality experts to provide the documentation you need to meet all ISO 13485, MDR, and FDA requirements.

In-House Engineering Capabilities

Optimized Design in a regulated environment

Our multidisciplinary  team embraces every project with a system approach. This holistic engineering practice coupled with 40 years’ experience in device design for manufacturing (DFM) allow us to address complex and often technologically challenging products.

  • Functional & value analysis, design to cost
  • Documentation (Planning, Requirements, Architecture, Design and Traceability)
  • V-Cycle VMP from URS/SRS to V&V reports
  • Test strategy (Integration Testing, System Testing)
  • Modeling, simulation
  • Prototyping, feasibility, iterative development
  • Optimization
  • QMS – FDA 21 CFR part 820 & ISO 13485
  • Risk Management – MD ISO 14971
  • General Safety – IEC 60601-1, 21 CFR part 803
  • Usability – IEC 62366-1 and IEC 60601-1-6
  • Safety by design – IEC-61508

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