Life Sciences & Medical Devices
ContactComputer 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
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 sales@4realsim.com to obtain more information on the life sciences & medical devices services.
