Life Sciences & Medical Devices

Computer Modelling and Simulation

Medical Device & Human Body Modelling

Verification, Validation & Uncertainty Quantification

Regulatory Compliance

In-silico Medicine – Virtual Clinical Trials

Contact

Computer Modelling and Simulation

Computer Modeling and Simulating (CM&S) has the potential to accelerate the long and challenging development process of medical devices and to move faster to the market, while reducing significantly costs associated with development and V&V activities. International regulatory agencies like EMA or FDA are recognizing the vast opportunities of making CM&S the fourth column in the medical device development process, besides bench-top testing, in-vitro, and in-vivo studies.

4RealSim Life Sciences is a leading service provider in that field and offers a large array of sophisticated multi-physics simulation processes & tools that support all phases of the medical device development process – from virtual feasibility studies via classic device verification and validation analyses to augmenting your human clinical studies with corresponding modelling and simulations – the in-silico trial. We offer in the simulation services for the following physical domains:

  • Structural Mechanical Analyses
  • Computational Fluid Dynamics
  • Fluid-Structure Interaction
  • Heat-Transfer Analyses
  • Coupled Heat-Stress Analyses
  • Electromagnetic Analyses

4RealSim Life Sciences and medical devices

Virtual design explorations

4RealSim offers various simulation-, exploration-, and optimization-tools that dramatically improve the understanding of the design space at the beginning of a development phase, while in a later stage yield robust & optimized designs.

  • Parametric Modelling and Stress & Strain Analyses
  • Early Performance & Fatigue Assessment
  • Design Sensitivity Analysis / DoE
  • 6-sigma Analyses
  • Parametric & Non-parametric Design Optimization
  • Robust Design Optimization


Virtual device testing

4RealSim consultants have experience in a wide range of capabilities. Some of them include

  • Stress-Strain Analyses
  • Fatigue Analyses
  • Damage Tolerance Analysis
  • Crack Growth Analysis
  • Manufacturing Process Analysis
  • Drop Test & Vibration Analysis
  • Impact Analyses
  • Worst-Case Identification
  • Uncertainty Analysis & Propagation
  • Reliability Analysis
  • Tissue Damage Analysis


ASTM- / ISO-compliant services

4RealSim is offering the following fully ASTM- & ISO-compliant simulations services.

  • ASTM F2477: Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
  • ASTM F2477: ASTM F2514: Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
  • ASTM F2477: ASTM F2942: Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
  • ASTM F3067: Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
  • ASTM F2079: Elastic Recoil of Balloon-Expandable Stents
  • ASTM F3211: Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
  • ISO 25539-1: Cardiovascular implants — Endovascular devices — Part 1
  • ISO 25539-2: Cardiovascular implants — Endovascular devices — Part 2
  • ISO 5840-1: Cardiovascular implants — Cardiac valve prostheses — Part 1
  • ISO 5840-2: Cardiovascular implants — Cardiac valve prostheses — Part 2
  • ISO 5840-3: Cardiovascular implants — Cardiac valve prostheses — Part 3
  • ISO 14242-1 Implants for surgery — Wear of total hip-joint prostheses — Part 1
  • ISO 7206-4: Implants for surgery — Partial and total hip joint prostheses — Part 4
  • ISO 7206-6: Implants for surgery — Partial and total hip joint prostheses — Part 6
  • ISO 7206-10: Implants for surgery — Partial and total hip-joint prostheses — Part 10


Virtual clinical studies – in-silico

4RealSim is actively involved via various task forces & research projects (e.g. SimInSitu) to explore and develop computer models and simulation processes with the needed credibility necessary to generate in-silico clinical data for a device certification submission. 4RealSim is furthermore actively involved in defining the necessary regulatory framework to would allow in-silico methods to become a viable tool.



Simulation credibility and compliance

4RealSim offers simulation services, which are in full compliance with state-of-the-art standards and guidance to establish and document the needed credibility for the developed computer models and conducted simulation analyses. This includes generally problem-specific & risk-based model-verification, model-validation, and uncertainty quantification / propagation.

  • FDA Guidance – Reporting of Computational Modeling Studies in Medical Device Submissions
  • ASME V&V 10-2019 Standard for Verification and Validation in Computational Solid Mechanics
  • ASME V&V 20-2016 Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer
  • ASME V&V 40-2018 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices

CONTACT US

Contact lifesciences@4realsim.com to obtain more information on the life sciences & medical devices services.


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