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Intelligent Design Control

Intelligent Design Control

Complexity in the development of medical devices, especially for smart medical devices that include software and electronics, demands software solutions to establish design controls that orchestrate the design process across inter-disciplinary engineering teams.

Intelligent Design Control is our solution for medical device companies to become data-driven, model-based, and document smart. Intelligent Design Control increases engineering efficiency and speed across the device lifecycle while avoiding costly errors, quality issues, and recalls.

Complexity in the development of medical devices, especially for smart medical devices that include software and electronics, demands software solutions to establish design controls that orchestrate the design process across inter-disciplinary engineering teams.

Intelligent Design Control is our solution for medical device companies to become data-driven, model-based, and document smart. Intelligent Design Control increases engineering efficiency and speed across the device lifecycle while avoiding costly errors, quality issues, and recalls.

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Product development data management, learn from Sartorius AG

Leveraging information for modeling, data management and regulatory requirements

Intelligent Design Control

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The development of modern, complex medical devices is a big challenge, especially for smart medical devices which increasingly use software and electronics to deliver essential therapeutic and diagnostic capabilities. Establishing regulatory-mandated design controls by tracking and tracing the network of user needs, risks, design requirements, and verification and validation testing can become overwhelming without the use of software-based solutions.

The risk of incomplete, incorrect data can lead to errors, quality issues, loss of time, poor performance, and significantly increase the likelihood of recalls. Intelligent Design Control is our holistic solution for integrating requirements and risk management, test planning and execution, and design output management, including Design History Files (DHF) and Device Master Records (DMR).

Enable your medical device company to become data-driven and document smart by powering your design process across mechanical, electrical, and software engineering teams with increased speed and clarity to produce safe high-quality device designs. Furthermore, our smart solution supports devices throughout the entire lifecycle by re-using data and connecting it via digital threads to quickly respond to inquiries during regulatory reviews or sustaining incremental engineering changes.

Intelligent Design Control
주요 고객 성공 사례

Cercacor

Healthcare technology innovator uses Polarion software to reduce test creation time by up to 75 percent

Siemens PLM Software helps Cercacor create visibility and accountability across testing programs

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온디맨드 웨비나

Intelligent Design Control – Verification & Validation

Intelligent Design Control – Verification & Validation

Next-Generation Design Control: Watch the second of this three-part series on Intelligent Design Control – Verification and Validation through test case management, contextualization, and claim substantiation.

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솔루션 기능

Explore the key areas of this solution.

Design Output Management

Enable companies to efficiently synchronize all data, domains and functional areas, including secure supplier collaboration. Provide a scalable, best-in-class platform for integrating outputs from all engineering disciplines.

Document Control

Avoid copy mistakes, ensure the integrity of data, manage medical device records and provide traceability across entire device lifecycle.

Materials Data & Lifecycle Management

Material information and how it’s managed can have a profound effect on your product’s lifecycle, and materials data management often plays a role in the success of the product.

Model Based Systems Engineering

Teamcenter 내 SDPD(시스템 기반 제품 개발) 솔루션이 멀티 도메인 제품 개발(기계, 전기 및 소프트웨어)과 비용, 신뢰성 및 제조 가능성 등의 고려 사항을 모두 지원합니다. 

Product Requirements Engineering

요구 사항의 가치는 파악하는 데 있는 것이 아니라 제품 개발 프로세스를 주도하는 데에 있습니다. Teamcenter는 다양한 다운스트림 기능/형상/제품 아키텍처에 요구 사항을 할당하며, 이 모두는 보고서, 문서 및 대시보드를 생성하여 요구 사항 프로세스를 관리하는 동안 이루어집니다. Microsoft Word 및 Excel을 포함한 비슷한 Microsoft Office 애플리케이션에서 직접 요구 사항을 생성, 보기 및 편집할 수 있습니다. 라이프사이클 통합 요구 사항을 통해 전체 제품 라이프사이클에서 "통합을 시작하고 유지"한 개발 프로세스를 지원할 수 있습니다.

Simulation Management

CAE 및 시스템 시뮬레이션을 효율적으로 관리하고 모든 의사결정권자가 제품 성능을 더 잘 이해할 수 있도록 공유하여 보다 확실하고 빠르게 혁신을 제공합니다.

Software Requirements Management

Capture and communicate requirements with an integrated platform designed specifically for medical device organizations.

Verification & Validation

Teamcenter의 요구 사항 확인 및 검증 기능은 집중적인 테스트를 지원하는 한편, 확인 및 검증 결과를 포착하고 요구 사항과 연결하여 요구 사항에 대한 폐쇄 루프를 실현할 수 있도록 지원합니다. Teamcenter 요구 사항 관리 솔루션에는 폐쇄 루프 프로세스 안에 요구 사항이 포함되어 있으며, 여기에는 요구 사항을 확인 및 검증(V&V)하는 방법이 요구 사항과 연결되어 있습니다. Teamcenter에는 테스트 및 검증 관리 기능도 포함되어 있으므로, 요구 사항을 테스트 항목들과 연결하여 검증할 수 있습니다.

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