Simulation & Testing for Medical Devices

Simulation & Testing for Medical Devices

Simulation is playing an increasingly significant role in the development of medical devices, saving development costs by optimizing device performance and reliability, reducing benchtop tests and clinical trials, and helping to speed the regulatory approval process.

Developing increasingly complex medical devices requires increasingly capable tools for simulation and testing. Our deep portfolio of simulation and testing solutions allows medical device developers to generate digital evidence of device performance across a range of engineering disciplines, throughout the product life cycle.

Simulation is playing an increasingly significant role in the development of medical devices, saving development costs by optimizing device performance and reliability, reducing benchtop tests and clinical trials, and helping to speed the regulatory approval process.

Developing increasingly complex medical devices requires increasingly capable tools for simulation and testing. Our deep portfolio of simulation and testing solutions allows medical device developers to generate digital evidence of device performance across a range of engineering disciplines, throughout the product life cycle.

Life sciences special report

The state of the art in CFD simulation in the Medical Device industry

Life Sciences Special Report

The life sciences sector is experiencing an unprecedented change in the way new medical devices and pharmaceuticals are developed. Leading medical companies have realized that investing in modeling and simulation is critical, and have started integrating simulation into clinical trials and applying it to modernize their manufacturing processes. Ultimately, this results in better medicines, superior medical products, and significantly improved outcomes for patients. The articles in this special report highlight a few examples of this and cover a range of applications from medical device design to pharmaceutical manufacturing processes.

Simulation & Testing for Medical Devices

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There has never been a greater opportunity to innovate in the design of medical devices, and to deal with the challenges of device development. Simulation is playing a critical role in identifying and preventing design-related failures, which continues to be the leading cause of device recalls. Simulation can increase product performance, safety and reliability, especially when performed early in the design cycle. And with the continuing rise in the cost of clinical trials, simulation-based product development, and virtual prototyping are increasingly being recognized by the US FDA as tools capable of supplementing experimental testing and clinical trials, and facilitating regulatory approval. Medical device developers can use simulation to generate digital evidence of product performance, an effort supported by FDA and regulatory agencies worldwide.

Engineers need tools that enable them to develop the most complete understanding of the complex processes occurring in the devices they design and troubleshoot, levels of understanding far beyond that provided by experiments or basic engineering principles. These tools should also allow engineers to explore the design space to understand the complex non-linear relationships between the relevant variables, then use the knowledge to inform trade-off decisions and provide insight into how products respond to the effects of variability, all while maintaining records of the simulation results and providing traceability between requirements and engineering data.

Simulation & Testing for Medical Devices
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Miele (Medical Instruments)

A better way to make medical instruments come clean

In an effort to continuously improve its product lines, Miele uses Simcenter Amesim for improving the development of its washer-disinfector machines.

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온디맨드 웨비나 | 58 분

디지털 증거 생성: 컴퓨터 시뮬레이션을 사용한 의료 기기 평가에 대한 FDA의 관점

디지털 증거 생성은 FDA와 전 세계 규제 기관이 지원하는 시뮬레이션을 사용한 제품 성능 구현 프로세스입니다.

의료 기기 개발 및 규제 평가에 시뮬레이션 (디지털 증거 생성)을 사용하는 방안에 대한 FDA의 관점에 대해 알아보십시오.

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