Comprehensive design of medical devices in accordance with the specific regulations for medical devices (ISO 13485).
Our lean methodology aims to minimise development costs by making use of digital tools before proceeding to the experimentation phases.
Depending on the type of product, specific simulation environments are used intensively to configure the best alternatives for PMVs (Minimum Viable Product).
The rapid prototyping systems allow us to quickly test the simulation results experimentally and select the best alternatives.
In this way it is possible to minimise the resources needed to obtain the final design that will be subjected to the different stages of validation with the least number of changes.
All of this contributes both to risk analysis in each of the design stages and to the traceability of the documentation throughout the development cycle.
Design, calculation and simulation applications:
• 3DEXPERIENCE® SOLIDWORKS (2021)
• CAD SolidWorks.
• PDM Solidworks.
• FEM – MSC, Altair Optistruct, Ansys.
• CFD - Fluent, Flow.
• Mutibody Dynamics Simulation- Adams, Motion.
• Multiphysics dynamic modelling - Modelica.
• Dynamic multi-domain modelling – Simulink.
Formlab SLA Form3 3D Printer.
• Biocompatible medical grade materials
• XY resolution: 25 microns.
• Laser power: 250 mW.
• Build volume: 14.5 x 14.5 x 18.5 cm.
• Layer thickness: 25 - 300 microns.
ISO 13485 certified
For multiple polymeric materials in filament and pellet format.
Stratasys Dimension 1200es FDM 3D printer
• material: ABSplus in 9 colours
• working area: 254 x 254 x 305 mm
• layer thickness: 0.33 mm or 0.254 mm
Analysis of idea / product
Product Assessment on ISO 13485
Proof of concept
Strategic advice and support in the (co) development of new products or services (evaluation of ideas, specifications, early dialogue and health technology assessment, etc.)
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link will present you with the best proposal for incorporating 4.0 solutions